| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Andersen (Controls unexposed, NOS), 2014 |
Denmark 1997 - 2010 |
All pregnancies in Denmark during the study period. | Pregnant women dispensing of a prescription of fluoxetine, citalopram, paroxetine, sertraline or escitalopram (at least the first 35 days of pregnancy). |
unexposed (general population or NOS)
Pregnant women without dispensation of Selective Serotonin Reuptake Inhibitors (SSRIs) during the first 35 days of pregnancy. |
22884 / 1256956 | |
| Andersen (Controls unexposed, sick), 2014 |
Denmark 1997 - 2010 |
All pregnancies in Denmark during the study period. | Pregnant women dispensing of a prescription of fluoxetine, citalopram, paroxetine, sertraline or escitalopram (at least the first 35 days of pregnancy). |
unexposed, sick
Pregnant women with dispensation of Selective Serotonin Reuptake Inhibitors (SSRIs) 3–12 months before pregnancy but not after this period or during pregnancy. |
22884 / 14016 | |
| Andrade, 2009 |
USA 1996 - 2000 |
Female members older than 15 years of age who were admitted to a hospital for delivery of an infant were continuously enrolled in the health plan with prescription drug coverage for 1 year prior to the admission. | Infants whose mothers received a dispensing of selective serotonin reuptake inhibitors (SSRIs) during the third trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Random sample of infants whose mothers did not receive selective serotonin reuptake inhibitors (SSRIs) during the third trimester. |
933 / -9 | 1142 women (933 141 68) were exposed to antidepressant in 3rd trimester. Among these, only 38 with more than 1 class of antidepressant exposure. Exposure was considered as mono-class of antidepressants. |
| Avalos (Controls exposed to TCA), 2015 |
USA 2010 - 2012 |
Women who were screened for depression in early pregnancy, had a depression diagnosis or were taking antidepressant medications during pregnancy. | Pregnant women with at least one pharmacy dispensing of selective serotonin reuptake inhibitors (SSRIs) between the first day of the woman's last menstrual period (LMP) and 20 completed weeks of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women with at least one pharmacy dispensing of tricyclic antidepressant (TCA) between the first day of the woman's last menstrual period (LMP) and 20 completed weeks of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
1262 / 116 | Results of SSRI only and TCA only reported rather than 'SSRI only and SSRI plus other antidepressant' or 'TCA only and TCA plus other antidepressant'. |
| Avalos (Controls unexposed, disease free), 2015 |
USA 2010 - 2012 |
Women who were screened for depression in early pregnancy, had a depression diagnosis or were taking antidepressant medications during pregnancy. | Pregnant women with at least one pharmacy dispensing of selective serotonin reuptake inhibitors (SSRIs) between the first day of the woman's last menstrual period (LMP) and 20 completed weeks of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnant women without depression. |
1262 / 16402 | Results of SSRI only reported rather than 'SSRI only and SSRI plus other antidepressant'. |
| Avalos (Controls unexposed, sick), 2015 |
USA 2010 - 2012 |
Women who were screened for depression in early pregnancy, had a depression diagnosis or were taking antidepressant medications during pregnancy. | Pregnant women with at least one pharmacy dispensing of selective serotonin reuptake inhibitors (SSRIs) between the first day of the woman's last menstrual period (LMP) and 20 completed weeks of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with untreated depression (diagnosed between 6 months prior to the woman's last menstrual period (LMP) and 20 completed weeks of gestation). |
1262 / 1345 | Results of SSRI only reported rather than 'SSRI only and SSRI plus other antidepressant'. |
| Bakaysa, 2016 |
USA 2009 - 2014 |
Patients who delivered at the tertiary care center from during the study period. | Women who reported Selective Serotonin Reuptake Inhibitors (SSRI) use on admission. |
unexposed (general population or NOS)
Women who do not report Selective Serotonin Reuptake Inhibitors (SSRI) use on admission. |
112 / 224 | 'Fetal anomalies, stillbirths, and multiple gestations were excluded.'Women reported using the following: citalopram (n=23), escitalopram (n=4), paroxetine (n=2), fluoxetine (n=34), and sertraline (n=49). |
| Ban (Controls exposed to TCA), 2014 |
United Kingdom 1990 - 2009 |
All singleton live births for women aged 15– 45years in which the medical records of the mothers and the children were linked to provide prospectively recorded information throughout pregnancy and in the year before pregnancy. | Pregnant women with selective serotonin reuptake inhibitors (SSRIs) prescriptions from 4 weeks before to 12 weeks after the first day of the estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women with tricyclic antidepressants (TCAs) prescriptions from 4 weeks before to 12 weeks after the first day of the estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
7683 / 2428 | Exclusion of 9096 children (2.5% of the study population) whose mothers had bipolar disorder, schizophrenia, other serious psychotic disorders, or prescriptions for antimanic and antipsychotic drugs before childbirth. Overlapping with Petersen 2016. |
| Ban (Controls exposed to TCA), 2012 |
The United Kingdom (UK). 1990 - 2009 |
All clinically recognised singleton pregnancies among women aged 15– 45 years that ended in live birth, stillbirth, termination or miscarriage. | Pregnant women with prescriptions for any selective serotonin reuptake inhibitors (SSRIs) (alone - i.e. no other psychotropic medication of interest) during the first trimester. |
exposed to other treatment, sick
Pregnant women with prescriptions for any tricyclic antidepressants (TCAs) (alone - i.e. no other psychotropic medication of interest) during the first trimester. |
14191 / 4349 | Mothers were grouped into eight mutually exclusive categories according to their diagnostic and treatment status. |
| Ban (Controls unexposed, disease free), 2014 |
United Kingdom 1990 - 2009 |
All singleton live births for women aged 15– 45 years in which the medical records of the mothers and the children were linked to provide prospectively recorded information throughout pregnancy and in the year before pregnancy. | Pregnant women with selective serotonin reuptake inhibitors (SSRIs) prescriptions from 4 weeks before to 12 weeks after the first day of the estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnant women without diagnosis of depression. |
7683 / 325294 | Exclusion of 9096 children (2.5% of the study population) whose mothers had bipolar disorder, schizophrenia, other serious psychotic disorders, or prescriptions for antimanic, antipsychotic drugs before childbirth. Overlapping with Petersen 2015 and 2016. |
| Ban (Controls unexposed, disease free), 2012 |
The United Kingdom (UK). 1990 - 2009 |
All clinically recognised singleton pregnancies among women aged 15– 45 years that ended in live birth, stillbirth, termination or miscarriage. | Pregnant women with prescriptions for any selective serotonin reuptake inhibitors (SSRIs) (alone - i.e. no other psychotropic medication of interest) during the first trimester. |
unexposed, disease free
Pregnant women without any indication of current or prior depression or anxiety. |
14191 / -9 | Mothers were grouped into eight mutually exclusive categories according to their diagnostic and treatment status. Number of unexposed women not provided. |
| Ban (Controls unexposed, sick), 2014 |
United Kingdom 1990 - 2009 |
All singleton live births for women aged 15– 45years in which the medical records of the mothers and the children were linked to provide prospectively recorded information throughout pregnancy and in the year before pregnancy. | Pregnant women with selective serotonin reuptake inhibitors (SSRIs) prescriptions from 4 weeks before to 12 weeks after the first day of the estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with depression diagnosed in the year before conception up to the end of the first trimester, but with no antidepressant drug prescriptions in the first trimester. |
7683 / 13432 | Exclusion of 9096 children (2.5% of the study population) whose mothers had bipolar disorder, schizophrenia, other serious psychotic disorders, or prescriptions for antimanic, antipsychotic drugs before childbirth. Overlapping with Petersen 2015 and 2016. |
| Ban (Controls unexposed, sick), 2012 |
The United Kingdom (UK). 1990 - 2009 |
All clinically recognised singleton pregnancies among women aged 15– 45 years that ended in live birth, stillbirth, termination or miscarriage. | Pregnant women with prescriptions for any selective serotonin reuptake inhibitors (SSRIs) (alone - i.e. no other psychotropic medication of interest) during the first trimester. |
unexposed, sick
Pregnant women with un-medicated depression or anxiety, i.e with current depression or anxiety but no prescriptions during the first trimester. |
14191 / -9 | Mothers were grouped into eight mutually exclusive categories according to their diagnostic and treatment status. Number of unexposed women not provided. |
| Batton, 2013 |
USA 2000 - 2008 |
Preterm singleton with in utero SSRI exposure and neurodevelopmental assessment in the DCC at 24 to 36 months, and their matched unexposed controls. | Infants born preterm after in utero Selective serotonin reuptake inhibitors (SSRIs) exposure. |
unexposed, disease free
Infants without in utero Selective serotonin reuptake inhibitors (SSRIs) exposure and for which the mothers had no signs or symptoms of depression and no history of previous antidepressant treatment. |
19 / 19 | |
| Benevent, 2023 |
France 2004 - 2019 |
Pregnancies covered by the French Health Insurance System of Haute-Garonne during the study period. | Pregnant women with at least one redeemed prescription of Selective serotonin reuptake inhibitors (SSRIs) monotherapy at least during the first trimester of pregnancy. |
unexposed (general population or NOS)
Pregnant women without redeemed prescription of antidepressants 3 months before and during pregnancy. |
1316 / 141865 | Data of the publication of Benevent 2023 completed with data of the unpublished report of Araujo 2022. Exclusion of receipt of both SSRIs and SNRIs 3 months before and during pregnancy. Results versus SNRIs not reported => inadequate control group. |
| Bérard - Non Sertraline SSRI, 2015 |
Canada 1998 - 2010 |
Pregnancies with continuous prescription drug insurance coverage of at least 12 months before the 1DLMP and during pregnancy; pregnancies with a diagnosis of depression and/or anxiety or exposed to antidepressants in the 12 months before pregnancy. | Depressed/anxious pregnancies with prescription fillings for Non-Sertraline selective serotonin reuptake inhibitors (paroxetine, citalopram, fluoxetine, and fluvoxamine) dispensed during the first trimester of gestation. |
unexposed, sick
Pregnancies with a diagnosis or were treated with antidepressants in the year before their pregnancy but with no exposure to antidepressants (sertraline or others) during the first trimester of gestation. |
1963 / 14868 | 2 group of SSRIs studied here => to avoid redundancy of control, only the non sertraline group was used. Overlapping: Ramos 2008 (1998-2002) included in this larger study. For major malfo: Bérard 2017 ('SSRI' as a whole) was used rather than Bérard 2015. |
| Bérard a, 2017 |
Canada 1998 - 2010 |
All pregnancies with continuous prescription drug insurance coverage of at least 12 months before and during pregnancy, and resulting in a singleton live birth, during the study period in the province of Quebec. | Women that had filled at least one prescription for selective serotonin receptor inhibitors (SSRIs) during the time window of interest (between week 21 and date of birth). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Women that did not have filled prescription for antidepressant during the time window of of interest (between week 21 and date of birth). |
1537 / 141097 | |
| Bérard b (Controls exposed to TCA), 2017 |
Canada 1998 - 2009 |
Pregnancies ending with a live-born singleton with continuous prescription drug insurance coverage of at least 12 months before the 1DLMP and during pregnancy; pregnancies with a diagnosis of depression and/or anxiety or exposed to antidepressants in the 12 months before pregnancy. | Depressed/anxious pregnancies with prescription fillings for Selective serotonin reuptake inhibitors (SSRI) dispensed during the first trimester of gestation. |
exposed to other treatment, sick
Depressed/anxious pregnancies with prescription fillings for Tricyclic antidepressants (TCA) dispensed during the first trimester of gestation. |
2327 / 382 | Overlapping: results of Ramos 2008 (1998-2002) are included in this larger study. For major malformations Bérard 2017 (that studied 'SSRI' as a whole) was used rather than Bérard 2015 (2 groups of exposure: Sertraline and 'other SSRIs'). |
| Bérard b (Controls unexposed, sick), 2017 |
Canada 1998 - 2009 |
Pregnancies ending with a live-born singleton with continuous prescription drug insurance coverage of at least 12 months before the 1DLMP and during pregnancy; pregnancies with a diagnosis of depression and/or anxiety or exposed to antidepressants in the 12 months before pregnancy. | Depressed/anxious pregnancies with prescription fillings for Selective serotonin reuptake inhibitors (SSRI) dispensed during the first trimester of gestation. |
unexposed, sick
Pregnancies with a diagnosis or were treated with antidepressants in the year before their pregnancy but with no exposure to antidepressants during the first trimester of gestation. |
2327 / 14847 | Overlapping: results of Ramos 2008 (1998-2002) are included in this larger study. For major malformations Bérard 2017 (that studied 'SSRI' as a whole) was used rather than Bérard 2015 (2 groups of exposure: Sertraline and 'other SSRIs'). |
| Bernard, 2019 |
Canada 2005 - 2010 |
Pregnant women aged 18 years or older without chronic hepatic or renal disease recruited during their first prenatal visit. | Pregnant women exposed to Selective serotonin reuptake inhibitors (SSRI) before the 16th week of pregnancy. |
unexposed, disease free
Pregnant women not exposed to the antidepressant/anxiolytic medication, depression or anxiety. |
117 / 6502 | |
| Bhatt-Mehta, 2019 |
USA 2009 - 2017 |
Infants of mothers at least 18 years of age, who presented at anytime during pregnancy and began follow-up in the high-risk clinic were eligible for the study if they were receiving methadone or buprenorphine maintenance therapy at any time during pregnancy for treatment of opioid dependence. | Infants with in-utero exposure to Selective Serotonin Reuptake Inhibitors (SSRIs) and opioids. |
unexposed, sick
Infants with in-utero exposure to opioids. |
27 / 109 | |
| Bliddal (Controls unexposed, NOS), 2023 |
Denmark 1997 - 2015 |
Singleton children born during the study period | Singletons whose mothers redeemed any prescriptions on Selective serotonin reuptake inhibitor (SSRI) (ATC code N06AB) from 30 days prior to conception (which was defined as day of delivery minus gestational age) to the day of delivery. |
unexposed (general population or NOS)
Singletons whose mothers have no redeemed Selective serotonin reuptake inhibitor (SSRI) prescriptions from 2 years before conception until day of delivery. |
22347 / 1094202 | Negative controls reporting confusion biais. Overlapping: Liu 2017 (1998 - 2012) included in Bliddal 2023 (1997 - 2015) => Only Bliddal 2023 used here because more exposed pregnancies. |
| Bliddal (Controls unexposed, sick), 2023 |
Denmark 1997 - 2015 |
Singleton children born during the study period | Singletons whose mothers redeemed any prescriptions on Selective serotonin reuptake inhibitor (SSRI) (ATC code N06AB) from 30 days prior to conception (which was defined as day of delivery minus gestational age) to the day of delivery. |
unexposed, sick
Singletons whose mothers who used a Selective serotonin reuptake inhibitor (SSRI) between 2 years and 30 days prior to conception, but not during pregnancy. |
-9 / -9 | Negative controls reporting confusion biais. Overlapping: Liu 2017 (1998 - 2012) included in Bliddal 2023 (1997 - 2015) => Only Bliddal 2023 used here because more exposed pregnancies. |
| Boukhris (Controls exposed to TCA), 2016 |
Canada 1998 - 2009 |
All full-term (≥37 weeks’ gestation) singleton infants born during the study period and whose mothers were covered by the RAMQ drug plan for at least 12 months before and during pregnancy. | Infants who mothers having at least 1 prescription of selective serotonin reuptake inhibitors (SSRIs) filled at any time during pregnancy or before pregnancy that overlapped the first day of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women having at least 1 prescription of Tricyclic antidepressants filled at any time during pregnancy or before pregnancy that overlapped the first day of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
1583 / 229 | 'Exposure to a single class was defined as the filling of prescriptions for only 1 AD class in the time window of interest.' |
| Boukhris (Controls exposed to TCA), 2017 |
Canada 1998 - 2009 |
All full-term (≥37 weeks of gestation) singletons born alive during the study period in the province of Quebec and whose mothers were covered by the RAMQ drug plan for at least 12 months before and during pregnancy. | Having at least one prescription filled of selective serotonin reuptake inhibitors (SSRIs) during the 2nd/3rd trimesters of pregnancy. (This is a subgroup of exposure among the whole exposed group considered). |
exposed to other treatment, sick
Having at least one prescription filled of tricyclic antidepressants (TCAs) during the 2nd/3rd trimesters of pregnancy. (This is a subgroup of exposure among the whole exposed group considered). |
1561 / 227 | ‘Single class’ exposure was defined as the filling of prescrip- tions for only one AD class in the time window of interest. |
| Boukhris (Controls unexposed, NOS), 2016 |
Canada 1998 - 2009 |
All full-term (≥37 weeks’ gestation) singleton infants born during the study period and whose mothers were covered by the RAMQ drug plan for at least 12 months before and during pregnancy. | Infants who mothers having at least 1 prescription of selective serotonin reuptake inhibitors (SSRIs) filled at any time during pregnancy or before pregnancy that overlapped the first day of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants who were not exposed in utero to antidepressants. |
1583 / 142924 | 'Exposure to a single class was defined as the filling of prescriptions for only 1 AD class in the time window of interest.' |
| Boukhris (Controls unexposed, NOS), 2017 |
Canada 1998 - 2009 |
All full-term (≥37 weeks of gestation) singletons born alive during the study period in the province of Quebec and whose mothers were covered by the RAMQ drug plan for at least 12 months before and during pregnancy. | Having at least one prescription filled of selective serotonin reuptake inhibitors (SSRIs) during the 2nd/3rd trimesters of pregnancy. (This is a subgroup of exposure among the whole exposed group considered). |
unexposed (general population or NOS)
Infants who were not exposed in utero to any antidepressants during the 2nd/3rd trimesters of pregnancy. |
1561 / 141905 | ‘Single class’ exposure was defined as the filling of prescrip- tions for only one AD class in the time window of interest. |
| Bracero, 2016 |
USA 2003 - 2009 |
Women on methadone maintenance who had live births during the study period, at a tertiary medical center in West Virginia. | Pregnant women on both methadone and Selective serotonin reuptake inhibitors (SSRIs) at the time of delivery. |
unexposed, sick
Pregnant women on methadone at the time of delivery. |
6 / 85 | The SSRIs used by the 6 patients were sertraline (2), fluoxetine (2), paroxetine (1), and escitalopram (1). |
| Brennan, 2023 |
USA Not specified. |
Mother-child dyads from the ECHO-wide Cohort with available data on prenatal exposure to antidepressants as well as measures of ASD and/or autism- related traits collected when the child was between 1 and 12 years of age. | Prenatal exposure to selective serotonin reuptake inhibitors (SSRIs). |
unexposed (general population or NOS)
No prenatal exposure to any antidepressants. |
117 / 2966 | Exposure to SSRI about 72% of the 163 mothers with any antidepressant use (i.e 117). The most common SSRI medications were paroxetine and sertraline. |
| Brown, 2017 |
Canada 2002 - 2010 |
Singleton children born in Ontario hospitals whose mothers were between the ages of 16 and 50 years and eligible for public drug benefits during pregnancy. | Pregnant women with 2 or more consecutive prescriptions for a selective serotonin reuptake inhibitor (SSRI) medication filled between conception and delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women with no serotonergic antidepressants prescribed during pregnancy or within 90 days prior to conception. |
2167 / 33069 | |
| Brown (Controls unexposed, disease free), 2016 |
Finland 1996 - 2010 |
Singleton live births during the study period. | Mothers diagnosed as having depression or another psychiatric disorder associated with one or more purchases of Selective serotonin reuptake inhibitors (SSRIs) during the period from 30 days before pregnancy until the end of pregnancy. |
unexposed, disease free
Mothers without a psychiatric diagnosis associated with SSRI use or a history of purchasing antidepressants or antipsychotics any time prior to or during pregnancy. |
15596 / 31207 | |
| Brown (Controls unexposed, sick), 2016 |
Finland 1996 - 2010 |
Singleton live births during the study period. | Mothers diagnosed as having depression or another psychiatric disorder associated with one or more purchases of Selective serotonin reuptake inhibitors (SSRIs) during the period from 30 days before pregnancy until the end of pregnancy. |
unexposed, sick
Mothers diagnosed as having depression or another psychiatric disorder (between 1 year before pregnancy and hospital discharge after delivery) associated with SSRI use with no history of SSRI purchase during pregnancy. |
15596 / 9537 | |
| Calderon-Margalit, 2009 |
USA 1996 - nr |
Pregnant mothers who initiated prenatal care before 20 weeks’ gestation and planned to deliver at either one of the two study hospitals. | Pregnant women who used Selective serotonin receptor inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who did not use psychotropic medications during pregnancy. |
132 / 2493 | Of the women who were taking psychotropic medications, 235 (78%) took only one medication, 51 (17%) used two medications, and 14 (5%) used three or more medications. |
| Cantarutti (Controls unexposed, NOS), 2016 |
Italy 2005 - 2010 |
Childbirths (liveborn) of women resident in Lombardy, an Italian Region with about 16% of the country’s population (almost ten million inhabitants). | Dispensation of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered). |
unexposed (general population or NOS)
No dispensation of antidepressants during the pregnancy. |
-9 / 374830 | |
| Cantarutti (Controls unexposed, sick), 2016 |
Italy 2005 - 2010 |
Childbirths (liveborn) of women resident in Lombardy, an Italian Region with about 16% of the country’s population (almost ten million inhabitants). | Dispensation of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered). |
unexposed, sick
Dispensation of antidepressants users just before conception, with at least an antidepressant dispensation in the 9 months before, but not during, pregnancy. |
-9 / 6548 | |
| Casper, 2003 |
USA Not specified |
Women who were in treatment in the Women’s Wellness Clinic or with other clinicians and who met DSM-IV criteria for Major Depressive Disorder during pregnancy. | Children of depressed mothers treated with selective serotonin reuptake inhibitors (SSRIs) at referral or started during pregnancy. |
unexposed, sick
Children whose mothers were diagnosed with major depressive disorder in pregnancy and elected not to take medication. |
31 / 13 | Continuous variables other that mental and psychomotor development not reported here. |
| Chambers - Fluoxetine, 1996 |
USA 1989 - 1995 |
Pregnant women who called the program requesting information on the potential teratogenic effects. | Pregnant women exposed to fluoxetine during pregnancy. |
unexposed (general population or NOS)
Pregnant women who called the program with questions about drugs and procedures not considered teratogenic. |
228 / 254 | |
| Chan (Controls exposed to TCA), 2024 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018. | Infants of women who were prescribed with Selective-serotonin-reuptake-inhibitors (SSRI) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
exposed to other treatment, sick
Infants of women who were prescribed with Tricyclic-antidepressants (TCA) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
956 / 322 | |
| Chan (Controls unexposed, general pop), 2024 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018. | Infants of women with prescription of Selective-serotonin-reuptake-inhibitors (SSRI) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
unexposed (general population or NOS)
Infants of pregnant women who were not prescribed with any antidepressant within 90 days before the last menstrual period and during the first trimester. |
956 / 462377 | |
| Chan (Controls unexposed, sick), 2024 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018. | Infants of women with depression/anxiety who were prescribed with Selective-serotonin-reuptake-inhibitors (SSRI) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
unexposed, sick
Infants of pregnant women with depression/anxiety who were not prescribed with any antidepressant within 90 days before the last menstrual period and during the first trimester. |
714 / 4413 | |
| Chen, 2021 |
Taiwan 2000 - 2013 |
Pregnant women aged 18–55 years with perinatal depression (ICD-9-CM codes 296.2–296.3 and 311) who were diagnosed with depression within 90 days before the date of their pregnancy test. | Pregnant patients with perinatal depression with selective serotonin reuptake inhibitors (SSRIs) prescription. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant patients with perinatal depression with no antidepressant treatment 90 days before the date of their first pregnancy. |
408 / 1789 | Meta-analysis of adjusted HR provided by authors according to defined daily doses. |
| Cohen, 2022 |
USA and United Kingdom 1999 - 2007 |
Healthy pregnant women from United Kingdom and pregnant women with histories of major depressive disorder (MDD) previously enrolled in the two prior studies conducted at the Massachusetts General Hospital (MGH), Boston, USA. | Child exposed in utero to an selective serotonin reuptake inhibitor (SSRI) (at any point during pregnancy). |
unexposed, disease free
Healthy developing control subjects, unexposed to selective serotonin reuptake inhibitors (SSRIs) in utero. |
54 / 18 | On average, children were exposed to an antidepressant during 90% of the pregnancy (SD=20%). |
| Colvin, 2011 |
Australia 2002 - 2005 |
All births in Western Australia during the study period. | Pregnant women who were dispensed an Selective Serotonin Reuptake Inhibitor (SSRI) during their pregnancy. |
unexposed (general population or NOS)
All other pregnant women and children of the women who were not dispensed a Selective Serotonin Reuptake Inhibitor (SSRI). |
3703 / 92995 | Overlapping of some outcomes (LBW, preterm, Apgar, Late intra-uterine death) with Colvin 2012 which include a little more pregnancies (and some adjustments and more relevant period of exposure), thus not reported here. |
| Colvin, 2012 |
Australia 2002 - 2005 |
All births in Western Australia during the study period. | Children born to women who had been dispensed a selective serotonin reuptake inhibitor (SSRI) at any time during their pregnancy. |
unexposed (general population or NOS)
Children born to women who had not been dispensed a selective serotonin reuptake inhibitor (SSRI) at any time during their pregnancy. |
3764 / 94561 | |
| Cornet - SSRIs, 2024 |
USA 2011 - 2019 |
Infants born at ≥37 weeks’ gestational age at 15 Kaiser Permanente Northern California (KPNC) hospitals between 1 November 2011 and 31 July 2019, whose mothers received prenatal care in KPNC. | Infants with any maternal Selective serotonin reuptake inhibitor (SSRI) dispensing by a KPNC pharmacy during late pregnancy, that is, after 20 weeks’ gestation. |
unexposed (general population or NOS)
Infants with no maternal Selective serotonin reuptake inhibitor (SSRI) dispensing by a KPNC pharmacy during late pregnancy, that is, after 20 weeks’ gestation. |
7573 / 272517 | SSRIs (ie, sertraline, fluoxetine, citalopram, escitalopram, paroxetine, dapoxetine, vortioxetine and fluvoxamine) => included non-SSRI (vortioxetine), but very low number of exposures (< 90%) => considered as SSRIs. |
| Corti, 2019 |
Italy 2011- 2016 |
Women consulting the Maternal Unit of Obstetrics-Gynecology, Sacco Hospital. | Caucasian women with a diagnosis of depression and/or anxiety in treatment with selective serotonin reuptake inhibitors (SSRIs) before and during conception. |
unexposed, disease free
Caucasian women, without a psychiatric diagnosis and not exposed to psychotropic medications before and during pregnancy (the first two deliveries immediately after each SSRI case). |
42 / 85 | 'Women who stopped taking medication before or during labor were excluded from the study.'. ' Exclusion criteria for both groups were other psychotropic drugs' |
| Costei - Paroxetine (Controls unexposed, NOS), 2002 |
Canada 1996 - 1999 |
All pregnant women who called the Motherisk program. | Pregnant women exposed to paroxetine throughout the third trimester. |
unexposed (general population or NOS)
Pregnant women who used nonteratogenic drugs. |
55 / 27 | Authors also considered a mixed control group: women who used paroxetine only during the 1st and/or 2nd trimesters and women who used nonteratogenic drugs. => Not considered here because the 2 separate control group seem more relevant. |
| Costei - Paroxetine (Controls unexposed, sick), 2002 |
Canada 1996 - 1999 |
All pregnant women who called the Motherisk program. | Pregnant women exposed to paroxetine throughout the third trimester. |
unexposed, sick
Pregnant women who used paroxetine only during the first and/or second trimesters. |
55 / 27 | Authors also considered a mixed control group: women who used paroxetine only during the 1st and/or 2nd trimesters and women who used nonteratogenic drugs. => Not considered here because the 2 separate control group seem more relevant. |
| Davidson, 2009 |
Israel July - Dec 2005 |
Pregnant women who gave birth to singleton infants at Rabin Medical Center. | Pregnant women took Selective serotonin reuptake inhibitors (SSRIs) during the entire pregnancy |
unexposed, disease free
Healthy pregnant women who did not take Selective serotonin reuptake inhibitors (SSRIs) or other medications. |
21 / 20 | Women with diabetes, chronic hypertension, and cardiovascular diseases were excluded from participation in the study. Eight mothers (38%) received paroxetine, seven (33%) fluoxetine, and six (29%) citalopram. |
| Davis, 2007 |
USA 1996 - 2000 |
Female older than 15 years of age who were admitted to a hospital during study period for delivery of an infant and were continuously enrolled with prescription drug coverage for 1 year prior to the admission. | Fullterm infants exposed in utero to selective serotonin reuptake inhibitor (SSRI) (trimester of exposure according to outcomes). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Fullterm infants unexposed to selective serotonin reuptake inhibitor (SSRIs). |
1768 / 79759 | Polyhydramnios, Oligohydramnios, Poly- and/or oligo-hydramnios not reported because not sure that the 3rd trimester exposure occurred before outcome. |
| De Ocampo, 2016 |
USA and Canada 2004 - 2014 |
Pregnant women with live singleton birth who called the MotherToBaby phone line that resided in USA or Canada, that were no more than 20 weeks in gestation at the time of enrollment, and had no prior diagnosis of any major birth defects in the current pregnancy at the time of enrollment. | Pregnant women who use selective serotonin reuptake inhibitors (SSRIs) alone during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who did not use antidepressants at any time during pregnancy. |
157 / 3119 | Two exposed groups: discontinuers (women who discontinued use <20 weeks of gestation) or continuers (women who continued use ≥20 weeks of gestation). Continuers reported here because it maximize the potential effect and there are more pregnancies. |
| de Vries, 2013 |
The Netherlands 2007 - 2010 |
Mother-infant pairs from the catchment areas of two level-two hospitals in the northern part of the Netherlands (Medical Centre Leeuwarden and Wilhelmina Hospital Assen) and the nearby midwifery practices. | Selective serotonin reuptake inhibitors (SSRI) for depression and/or anxiety disorder during pregnancy and already taking medication before conception. |
unexposed (general population or NOS)
Pregnant women that did not use a Selective serotonin reuptake inhibitors (SSRI) (or psychotropic medication) during pregnancy (healthy or with depression and/or anxiety unmedicated). |
63 / 44 | 'Venlafaxine was considered to work as an SSRI if being dosed low; women using venlafaxine ,200 mg were included in the SSRI group'. Control group included: healthy women (n=35) and depressed unmedicated (n=9). |
| Diav-Citrin - Fluoxetine or Paroxetine, 2008 |
Israel, Italy and Germany 1994 - 2005 |
Women who contacted one of the three participating Teratology Information Services. | Pregnant women who contacted one Teratology Information Service regarding exposures to Fluoxetine or Paroxetine (sum of paroxetine and fluoxetine exposures). |
unexposed (general population or NOS)
Pregnant women who contacted one Teratology Information Service regarding exposures known not to be teratogenic in similar time frames. |
809 / 1467 | Monotherapy: Author's answer: 'As far as we know, all women were exposed to only one of these two drugs.' => Thus sum of paroxetine and fluoxetine exposures, except for the 2 adjusted results (use of Paroxetine data because more exposed pregnancies). |
| Dubnov-Raz, 2008 |
Israel 2000 - 2005 |
All of the newborns born at a single tertiary care hospital. | Newborns exposed to selective serotonin-reuptake inhibitor antidepressants in the immediate antepartum period. |
unexposed, disease free
Newborns born to healthy mothers who took no medications before delivery. |
52 / 52 | Paroxetine (n = 25), citalopram (n = 13), fluoxetine (n = 12), fluvoxamine (n = 1), and venlafaxine (n = 1) => Mainly SSRI (24/25), thus considered as SSRI. |
| Edelson, 2020 |
USA Not specified |
Pregnant women with opiate use disorder (OUD), with a singleton pregnancy without prenatally diagnosed genetic abnormalities or malformations, with at least 3 ultrasound visits, prenatal care and delivery at the institution. | Pregnant women who were on buprenorphine and selective serotonin reuptake inhibitors (SSRI). |
unexposed, sick
Pregnant women who were on buprenorphine without selective serotonin reuptake inhibitors (SSRI). |
12 / 37 | Two possible analyses: buprenorphine or methadone. The buprenorphine analysis was chosen because there is more exposed pregnancies to SSRI and induced less NAS. |
| Einarson, 2001 |
Canada, USA, Italy, and Brazil. Not specified |
Pregnant women that called pregnancy counseling centers. | Pregnant women suffering from depression who were taking selective serotonin reuptake inhibitors (SSRIs) (fluoxetine, sertraline, fluvoxamine, and paroxetine). |
unexposed (general population or NOS)
Pregnant women who were given nonteratogenic drugs (loperamide, echinacea, sumatriptan, and dextromethorphan). |
150 / 150 | Overlapping: The outcome 'Major malformation' is not reported here because a larger study published by Einarson et al. 2009 (n=506 SSRI exposures) could include the same cases. |
| Einarson, 2009 |
Canada Not specified. |
Women call the service for information regarding the safety of a drug. | Pregnant women who were exposed to selective serotonin reuptake inhibitors (SSRIs) in the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who were not exposed to antidepressants and who had called Motherisk for information regarding nonteratogenic drugs. |
527 / 928 | Addition of raw data provided for citalopram (184), escitalopram (21), fluvoxamine (52), paroxetine (148), fluoxetine (61) and sertraline (61). |
| Einarson - Paroxetine, 2008 |
Italy, Switzerland, Australia, Canada, Germany, Israel, USA and Finland Not specified. |
Pregnant women who called Teratology information services to inquire about the use of a drug they are taking. | First-trimester paroxetine exposure. |
unexposed (general population or NOS)
Other women who called teratology information services inquiring about exposures to drugs that are considered safe in pregnancy. |
1174 / -9 | Only the 1,174 unpublished cases of first-trimester paroxetine exposure from eight teratology information services were reported here. The other 2,061 cases from five previously published database studies are not reported here. |
| El Marroun (Control unexposed, disease free), 2014 |
The Netherlands 2002 - 2006 |
All pregnant women resident in Rotterdam were invited to participate. | Pregnant women who used Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, disease free
Pregnant women whitout exposure to Selective serotonin reuptake inhibitors (SSRIs) and a low score of maternal depressive symptoms. |
69 / 5531 | |
| El Marroun (Control unexposed, sick), 2014 |
The Netherlands 2002 - 2006 |
All pregnant women resident in Rotterdam were invited to participate. | Pregnant women who used Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, sick
Pregnant women with clinically relevant depressive symptoms and no maternal Selective serotonin reuptake inhibitors (SSRIs) use. |
69 / 376 | |
| El Marroun (Controls unexposed, disease free), 2012 |
The Netherlands 2002 - 2006 |
All pregnant women who resided in Rotterdam and whose delivery date was during the study period. | Women using Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, disease free
Women not using Selective serotonin reuptake inhibitors (SSRIs) with low depressive symptoms |
99 / 7027 | |
| El Marroun (Controls unexposed, sick), 2012 |
The Netherlands 2002 - 2006 |
All pregnant women who resided in Rotterdam and whose delivery date was during the study period. | Women using Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, sick
Women with clinically relevant depressive symptoms and not using Selective serotonin reuptake inhibitors (SSRIs). |
99 / 570 | |
| Engelstad (Controls unexposed, disease free), 2014 |
USA 2009 - 2011 |
Women who delivered at the University of Iowa Hospitals and Clinics (UIHC) during the study period. | Pregnant women who had an ICD-9 code for depression and who were prescribed selective serotonin reuptake inhibitors (SSRIs). |
unexposed, disease free
Pregnant women who did not have any of the ICD-9 codes for depression. |
126 / 222 | In exposed group: 'Two women received an SSRI plus bupropion, and one woman received sertraline plus bupropion and nortriptyline'=> considered as monotherapy of SSRI. |
| Engelstad (Controls unexposed, sick), 2014 |
USA 2009 - 2011 |
Women who delivered at the University of Iowa Hospitals and Clinics (UIHC) during the study period. | Pregnant women who had an ICD-9 code for depression and who were prescribed selective serotonin reuptake inhibitors (SSRIs). |
unexposed, sick
Pregnant women with depression that did not receive a selective serotonin reuptake inhibitors (SSRI) (with 82% of no antidepressant and 18% of other antidepressants). |
126 / 128 | In exposed group: 'Two women received an SSRI plus bupropion, and one woman received sertraline plus bupropion and nortriptyline'=> considered as monotherapy of SSRI. |
| Figueroa, 2010 |
USA 1997 - 2006 |
Children and their families for which there was information on service utilization by the mother during pregnancy and by the children until they were 4 years old; | Children born to mothers with a prescription filled of Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, sick
Children born to depressed mothers who were not exposed to antidepressants during pregnancy |
916 / 3532 | |
| Frayne, 2021 |
Australia Not specified |
Pregnant women with severe mental illnesses attending at two specialised tertiary obstetric hospitals. | Pregnant women that use Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women who were not taking, and had not taken, antidepressant, mood stabilizing and antiepileptic agents during the pregnancy. |
108 / 238 | 'Data were extracted from a larger dataset: Galbally et al. 2020' |
| Furu (Controls unexposed, NOS), 2015 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2010 |
Women who gave birth to a live singleton infant during the study period (different periods according to country). | Infants born to women who filled a prescription for a Selective serotonin reuptake inhibitors (SSRI) from 30 days before the first day of the last menstrual period until the end of the first trimester (defined as 97 days after the last menstrual period). |
unexposed (general population or NOS)
Infants not exposed to any antidepressant (ATC code N06A) in utero. |
36772 / 2266875 | The group Any SSRI included SSRI and Venlafaxine (less than 10% of exposed group (2763/36772=7.5%)), thus the 'Any SSRI' is considered as SSRI. Overlapping: Furu 2015 included Norby 2006, Malm 2005, Pedersen 2009, Wogelius 2006, Lennestal 2007. |
| Furu (Controls unexposed, sibling), 2015 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2010 |
Sibling singleton born to the same mother during these periods (different periods according to country) and who were discordant for both exposure and outcome (extraction of women with at least 2 children in the dataset). | Infants born to women who filled a prescription for a Selective serotonin reuptake inhibitors (SSRI) from 30 days before the first day of the last menstrual period until the end of the first trimester (defined as 97 days after the last menstrual period). |
sibling
Siblings born to the same mother but not exposed to any antidepressant (ATC code N06A) in utero. |
980 / 1308 | The exposed group Any SSRI included SSRI and Venlafaxine (not a SSRI). Venlafaxine represents less than 10% of exposed group (2763/36772=7.5%), thus the 'Any SSRI' group is considered to represent SSRI even if it includes Venlafaxine. |
| Galbally (Controls unexposed, disease free), 2020 |
Australia 2012 - 2017 |
Pregnant women recruited before the 20th week of pregnancy | Pregnant women taking Selective serotonin reuptake inhibitors (SSRIs) in pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnant women who met no diagnostic criteria and were not taking antidepressants. |
60 / 348 | Overlapping: results of preeclampsia specifically studied in Frayne 2021(with a little more pregnancies), thus results reported in Galbally 2020 not included in Metapreg. |
| Galbally (Controls unexposed, sick), 2020 |
Australia 2012 - 2017 |
Pregnant women recruited before the 20th week of pregnancy. | Pregnant women taking Selective serotonin reuptake inhibitors (SSRIs) in pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Non-medicated pregnant women who met diagnostic criteria on a structured interview for current or past (within 2 years of pregnancy) depression or dysthymia at recruitment. |
60 / 47 | Overlapping: results of preeclampsia specifically studied in Frayne 2021(with a little more pregnancies), thus results reported in Galbally 2020 not included in Metapreg. |
| Giardinelli (Controls unexposed, disease free), 2018 |
Italy 2014- 2015 |
Pregnant Caucasian women attending the outpatient clinic, age >18 years old, between 4th and 12th week of gestation and with diagnosis of major depression or consecutive healhty women. | Pregnant with diagnosis of major depression treated with selective serotonin reuptake inhibitors (SSRIs) and psychological support. |
unexposed, disease free
Consecutive healthy pregnant women. |
24 / 26 | |
| Giardinelli (Controls unexposed, sick), 2018 |
Italy 2014- 2015 |
Pregnant Caucasian women attending the outpatient clinic, age >18 years old, between 4th and 12th week of gestation and with diagnosis of major depression. | Pregnant with diagnosis of major depression treated with selective serotonin reuptake inhibitors (SSRIs) and psychological support. |
unexposed, sick
Pregnant with diagnosis of major depression treated with psychological support only. |
24 / 23 | |
| Gover, 2023 |
Israel 2015 - 2022 |
All preterm infants born during the study period and admitted to neonatal intensive care unit (NICU). | Preterm infants with a positive history of maternal Selective serotonin reuptake inhibitors (SSRIs) use throughout the pregnancy. |
unexposed (general population or NOS)
Preterm infants with a confirmed negative history of maternal Selective serotonin reuptake inhibitors (SSRIs) use throughout the pregnancy. |
21 / 21 | Because all included infants were admitted to neonatal intensive care unit (NICU), only the parameter 'Delivery room advanced resuscitation' was reported as a proxy of severity. |
| Grzeskowiak (Controls unexposed, disease free), 2013 |
Denmark 1996 - 2002 |
Pregnant women who signed the original consent form and completed both prenatal interviews. | Pregnant women that reported taking a selective serotonin reuptake inhibitor (SSRI) at any stage during pregnancy. |
unexposed, disease free
Pregnant women who did not have a psychiatric illness and did not receive a dispensing for an SSRI. |
127 / 35568 | Exclusion of women who took psychotropic medications other than SSRIs during pregnancy (i.e., anxiolytics, antipsychotics, antiepileptics or other antidepressants). |
| Grzeskowiak (Controls unexposed, sick), 2013 |
Denmark 1996 - 2002 |
Pregnant women who signed the original consent form and completed both prenatal interviews. | Pregnant women that reported taking a selective serotonin reuptake inhibitor (SSRI) at any stage during pregnancy. |
unexposed, sick
Pregnant women with a psychiatric illness during pregnancy but who did not receive a dispensing for an SSRI or any other antidepressant during pregnancy. |
127 / 490 | Exclusion of women who took psychotropic medications other than SSRIs during pregnancy (i.e., anxiolytics, antipsychotics, antiepileptics or other antidepressants). |
| Grzeskowiak a (Controls unexposed, disease free), 2012 |
Australia 2000 - 2008 |
All births in the Women’s and Children’s Health Network, a specialist metropolitan tertiary level teaching hospital and South Australia’s largest maternity and obstetric service provider. | Pregnant women that received a dispensing for a selective serotonin reuptake inhibitors (SSRI) during pregnancy. |
unexposed, disease free
Pregnant women who did not have a psychiatric illness and did not receive a dispensing for an SSRI. |
221 / 32004 | Exclusion of women who were taking antidepressants other than SSRIs during pregnancy (n = 93) and those who were taking antipsychotics (n = 81). |
| Grzeskowiak a (Controls unexposed, sick), 2012 |
Australia 2000 - 2008 |
All births in the Women’s and Children’s Health Network, a specialist metropolitan tertiary level teaching hospital and South Australia’s largest maternity and obstetric service provider. | Pregnant women that received a dispensing for a selective serotonin reuptake inhibitors (SSRI) during pregnancy. |
unexposed, sick
Pregnant women with a psychiatric illness during pregnancy but who did not receive a dispensing for an SSRI or any other antidepressant during pregnancy. |
221 / 1566 | Exclusion of women who were taking antidepressants other than SSRIs during pregnancy (n = 93) and those who were taking antipsychotics (n = 81). |
| Grzeskowiak b (Controls unexposed, disease free), 2012 |
Australia 2000 - 2005 |
Women who gave birth to singleton, live-born infants during the study period. | Pregnant women that received a dispensing for a selective serotonin reuptake inhibitors (SSRI) during pregnancy. |
unexposed, disease free
Pregnant women that did not have a reported psychiatric illness and did not receive a dispensing for any antidepressant. |
71 / 6285 | Exclusion of women who were dispensed an antidepressant other than SSRIs during pregnancy, antipsychotics, and anti-epileptics, as well as women with asthma, hypertension, diabetes, gestational diabetes and thyroid disorders. |
| Grzeskowiak b (Controls unexposed, sick), 2012 |
Australia 2000 - 2005 |
Women who gave birth to singleton, live-born infants during the study period. | Pregnant women that received a dispensing for a selective serotonin reuptake inhibitors (SSRI) during pregnancy. |
unexposed, sick
Pregnant women with a psychiatric illness during pregnancy but who did not receive a dispensing for an SSRI or any other antidepressant during pregnancy. |
71 / 204 | Exclusion of women who were dispensed an antidepressant other than SSRIs during pregnancy, antipsychotics, and anti-epileptics, as well as women with asthma, hypertension, diabetes, gestational diabetes and thyroid disorders. |
| Gungor (Controls exposed to Mirtazapine), 2019 |
Turkey 2015 - 2018 |
The pregnancies in women older than 18 with live and singleton births. | Pregnant women medicated with selective serotonine reuptake inhibitor (SSRI) as a single treatment. |
exposed to other treatment, sick
Pregnant women medicated with mirtazapine as a single treatment. |
40 / 16 | The exclusion criteria were the use of medications (including antihistaminic agents, benzodiazepines, herbal medicine, antipsychotics) other than SSRI or mirtazapine for psychiatric disorder... |
| Gungor (Controls unexposed, disease free), 2019 |
Turkey 2015 - 2018 |
The pregnancies in women older than 18 with live and singleton births. | Pregnant women medicated with selective serotonin reuptake inhibitors (SSRIs) as a single treatment. |
unexposed, disease free
Healthy women with no current nor previous psychiatric disorder history. |
40 / 23 | The exclusion criteria were the use of medications (including antihistaminic agents, benzodiazepines, herbal medicine, antipsychotics) other than SSRI or mirtazapine for psychiatric disorder... |
| Gungor (Controls unexposed, sick), 2019 |
Turkey 2015 - 2018 |
The pregnancies in women older than 18 with live and singleton births. | Pregnant women medicated with selective serotonin reuptake inhibitors (SSRIs) as a single treatment. |
unexposed, sick
Pregnant women with unmedicated psychiatric disorder. |
40 / 23 | The exclusion criteria were the use of medications (including antihistaminic agents, benzodiazepines, herbal medicine, antipsychotics) other than SSRI or mirtazapine for psychiatric disorder... |
| Hagberg (Controls exposed to TCA), 2018 |
United Kingdom 1989 - 2011 |
Mothers, aged 13–44 years, and their live-born, singleton infants born. | Pregnant women with depression treated with Selective serotonin reuptake inhibitors (SSRIs) only (diagnosis and ≥1 antidepressant prescription during the exposure period). (This is a subgroup of exposure among the whole exposed group considered). |
exposed to other treatment, sick
Pregnant women with depression treated with tricyclic antidepressants (TCAs) only (diagnosis and ≥1 antidepressant prescription during the exposure period). (This is a subgroup of exposure among the whole exposed group considered). |
17362 / 4856 | For ASD: Partial overlapping of Hagberg 2018 (1989 - 2011) and Heuvelman 2023 (1995 - 2017), with more uncommon study period (12 years) than common (6 years) => The 2 studies were kept. |
| Hagberg (Controls unexposed, disease free), 2018 |
United Kingdom 1989 - 2011 |
Mothers, aged 13–44 years, and their live-born, singleton infants born. | Pregnant women with depression treated with Selective serotonin reuptake inhibitors (SSRIs) only (diagnosis and ≥1 antidepressant prescription during the exposure period). (This is a subgroup of exposure among the whole exposed group considered). |
unexposed, disease free
Pregnant women who had neither depression nor prescriptions for antidepressants prior to the baby’s delivery date. |
17362 / 154107 | For ASD: Partial overlapping of Hagberg 2018 (1989 - 2011) and Heuvelman 2023 (1995 - 2017), with more uncommon study period (12 years) than common (6 years) => The 2 studies were kept. |
| Hagberg (Controls unexposed, sick), 2018 |
United Kingdom 1989 - 2011 |
Mothers, aged 13–44 years, and their live-born, singleton infants born. | Pregnant women with depression treated with Selective serotonin reuptake inhibitors (SSRIs) only (diagnosis and ≥1 antidepressant prescription during the exposure period). (This is a subgroup of exposure among the whole exposed group considered). |
unexposed, sick
Pregnant women with untreated depression (recent history of treated depression but no antidepressants during the exposure period). |
17362 / 12994 | For ASD: Partial overlapping of Hagberg 2018 (1989 - 2011) and Heuvelman 2023 (1995 - 2017), with more uncommon study period (12 years) than common (6 years) => The 2 studies were kept. |
| Handal a, 2016 |
Norway 1999 - 2008 |
Singleton pregnancies recruited from all over Norway | Pregnant women that report any use of selective serotonin reuptake inhibitors (SSRIs) from pregnancy week 0 until birth. |
unexposed (general population or NOS)
Pregnant women that did not report any use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
381 / 51023 | Addition of the 2 subgroups: 'One period' and 'At least two periods' of exposure during pregnancy. |
| Hanley, 2016 |
Canada 2002 - 2011 |
All women who delivered a live neonate in the Canadian province of British Columbia (population of 4.3 million). | A supply of selective serotonin reuptake inhibitors (SSRIs) during pregnancy (late- or mid-pregnancy exposure). (This is a subgroup of exposure among the whole exposed group considered). |
unexposed (general population or NOS)
No supply of any antidepressants in the 5 months before delivery (during mid- to late pregnancy) |
6637 / 310813 | 'We excluded all women using “other antidepressants” (such as amitriptyline, bupropion, and trazodone) from our final analyses. Women using combination SSRI and serotonin–norepinephrine reuptake inhibitor therapy were also excluded.' |
| Hannerfors (Controls unexposed, NOS), 2015 |
Sweden ? - 2013 |
Women with singleton and non pathologic pregnancy attending the routine ultrasound examination. | Pregnant women treated with serotonin reuptake inhibitors (SSRI) at the time of the blood sampling (16—20 weeks of gestation). |
unexposed (general population or NOS)
Untreated pregnant women. |
207 / 609 | |
| Hannerfors (Controls unexposed, sick), 2015 |
Sweden ? - 2013 |
Women with singleton and non pathologic pregnancy attending the routine ultrasound examination. | Pregnant women treated with serotonin reuptake inhibitors (SSRI) at the time of the blood sampling (16—20 weeks of gestation). |
unexposed, sick
Untreated depressed pregnant women. |
207 / 56 | |
| Heikkinen - Citalopram only, 2002 |
Finland Not specified. |
Pregnant women that visited the maternity unit of the Turku University Hospital during pregnancy. | Women taking citalopram during pregnancy and lactation. |
unexposed (general population or NOS)
Women with no medication prospectively matched for confounding obstetric characteristics (age, gravidity, parity, and time and mode of delivery) at the time of delivery. |
11 / 10 | Neurologic development not reported because not enough provided details. Ten of the women taking citalopram already had the medication at the time of conception, and one woman started the medication at 20 weeks. |
| Heikkinen - Fluoxetine only, 2003 |
Finland Not specified |
Pregnant women who visited the maternity unit of Turku University Hospital. | Pregnant women taking fluoxetine during pregnancy and lactation. |
unexposed (general population or NOS)
Pregnant women with no psychotropic medication was prospectively matched at the time of delivery. |
11 / 10 | Six of the women already used fluoxetine before conception, and they used fluoxetine throughout pregnancy and lactation. Five women started taking fluoxetine later during pregnancy (ie, at 22, 27, 31, 32, and 35 weeks of gestation). |
| Heinonen - Sertraline, 2021 |
Sweden 2016 - 2019 |
Pregnant women with moderate untreated depression recruited in Stockholm Region. | Pregnant women randomized to sertraline group with the daily dose starting at one capsule á 25 mg and increase up to up to a dose of four capsules when lacking treatment response. |
unexposed, sick
Pregnant women randomized to placeb group. |
9 / 6 | |
| Heuvelman, 2023 |
United Kingdom 1995 - 2017 |
Pregnancies in Clinical Practice Research Datalink (CPRD) with a history of depressive symptoms or use of antidepressants in the preceding year before pregnancy. | Women who had initiated or continued selective serotonin reuptake inhibitor (SSRI) for the treatment of depressive symptoms during pregnancy. |
unexposed, sick
Women who did not initiate or who discontinue antidepressants during pregnancy. |
12093 / 16330 | For ASD: Partial overlapping of Hagberg 2018 (1989 - 2011) and Heuvelman 2023 (1995 - 2017), with more uncommon study period (12 years) than common (6 years) => The 2 studies were kept. |
| Hogue, 2017 |
USA 2007 - 2014 |
Pregnant women who delivered at Hillcrest Hospital, a Level III 35-bed NICU, in the study period. | Neonates of mothers who were treated with selective serotonin reuptake inhibitors (SSRIs) or venlafaxine during pregnancy. |
unexposed (general population or NOS)
Neonates who were not exposed to elective serotonin reuptake inhibitors (SSRIs) or venlafaxine in- utero. |
168 / 166 | Venlafaxine less than 10% of the exposed group, thus considered as SSRI exposure. Separate analysis performed for preterm and full-term neonates. Analysis in Full term were reported here (because preterm could be a risk factor of the considered outcomes). |
| Hutchison a, 2019 |
Canada Not specified. |
Mothers recruited during their second trimester of pregnancy. | Pregnant women treated with selective serotonin reuptake inhibitor (SSRI) during pregnancy. |
unexposed, sick
Pregnant women with a range of mood symptoms at recruitment and over the subsequent 6 years, not treated by selective serotonin reuptake inhibitor (SSRI). |
42 / 74 | Child Daily Macronutrients, Sugar, and Sodium Intake at 6 Years and Continuous variables not reported here (excepted for Gross motor scale at 10 months). |
| Hutchison b, 2019 |
Canada Not specified |
Mothers and children of a study examining the effects of prenatal exposure to SSRIs and maternal mood disturbances. | Infants of Selective Serotonin Reuptake Inhibitor (SSRI)-treated mothers had a diagnosed mood disorder and had started taking medications based on clinical need. |
unexposed, sick
Infants of women without Serotonin Reuptake Inhibitor (SSRI) use but who had a range of mood symptoms at the time of recruitment and over the subsequent 6 years. |
51 / 88 | |
| Huybrechts (Controls unexposed, NOS), 2014 |
USA 2000 - 2007 |
All completed pregnancies and their linked liveborn infants. | Pregnant women who have had exposure to selective serotonin-reuptake inhibitors (SSRIs) with the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women without exposure to antidepressants during the first trimester. |
46144 / 885115 | Exclusion of pregnancies with a diagnosis of a chromosomal abnormality and pregnancies in which the mother had been treated with known teratogens during the first trimester (i.e., lithium, antineoplastic agents, retinoids, and thalidomide). |
| Huybrechts (Controls unexposed, NOS), 2015 |
USA 2000 – 2010 |
All completed pregnancies in women aged 12 to 55 years, Medicaid beneficiaries, and linked these pregnancies to live-born infants | Pregnant women who filled at least 1 prescription for a selective serotonin reuptake inhibitors (SSRI) from 90 days before delivery through delivery. |
unexposed (general population or NOS)
Pregnant women without exposure to antidepressants at any time during pregnancy. |
102179 / 3660380 | Women exposed to both SSRIs and non-SSRIs were excluded from the cohort. |
| Huybrechts (Controls unexposed, sick), 2015 |
USA 2000 – 2010 |
All completed pregnancies in women aged 12 to 55 years, Medicaid beneficiaries, and linked these pregnancies to live-born infants | Pregnant women who filled at least 1 prescription for a selective serotonin reuptake inhibitors (SSRI) from 90 days before delivery through delivery. |
unexposed, sick
Pregnant women with a depression diagnosis without exposure to antidepressants at any time during pregnancy. |
65316 / 657515 | Women exposed to both SSRIs and non-SSRIs were excluded from the cohort. |
| Huybrechts (Controls unexposed, sick), 2014 |
USA 2000 - 2007 |
All completed pregnancies and their linked liveborn infants. | Pregnant women who have had exposure to selective serotonin-reuptake inhibitors (SSRIs) with the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with a diagnosis of depression without exposure to antidepressants during the first trimester. |
36778 / 180564 | Exclusion of pregnancies with a diagnosis of a chromosomal abnormality and pregnancies in which the mother had been treated with known teratogens during the first trimester (i.e., lithium, antineoplastic agents, retinoids, and thalidomide). |
| Isohata, 2025 |
Japan 2019 - 2023 |
Pregnancies complicated by maternal mental disorders that resulted in full-term deliveries at Kitasato University Hospital from 2019–2023. | Pregnancies complicated by maternal mental disorders that have taken Selective serotonin reuptake inhibitors (SSRIs) at the time of admission for delivery. |
unexposed, sick
Pregnancies complicated by maternal mental disorders that have not taken psychotropic medications at the time of admission for delivery. |
42 / 177 | Psychotropic medications included: antipsychotics (typical or atypical), antidepressants, anti-anxiety, anti-epileptic and slee-inducing. |
| Jackson, 2024 |
U.S.A 2019 - 2022 |
All pregnant patients who delivered at 23 weeks of gestational age or greater at seven hospitals within a large academic health system in New York. | Prenatal exposure to a monotherapy of selective serotonin reuptake inhibitors (SSRIs: escitalopram, fluoxetine, sertraline). |
unexposed, disease free
No prenatal exposure to selective serotonin reuptake inhibitors (SSRIs: escitalopram, fluoxetine, sertraline). |
2106 / 105000 | |
| Jaeger, 2019 |
USA 2014 - 2017 |
Women enrolled in the Military Healthcare System (MHS) and admitted for childbirth during the study period. | Pregnant women using Selective Serotonin Reuptake Inhibitor (SSRI) during the 3 months before and at each trimester of pregnancy. |
unexposed (general population or NOS)
Pregnant women not using Selective Serotonin Reuptake Inhibitor (SSRI) during pregnancy. |
-9 / -9 | |
| Jensen b, 2013 |
Denmark 1996 - 2006 |
All singleton live births occurring during the study period. | Live births whose mother redeemed a prescription for selective serotonin reuptake inhibitors during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Live births whose mother without a diagnosis of depression as well as to antidepressants. |
7208 / 628898 | |
| Jimenez-Solem (Controls unexposed, NOS), 2012 |
Denmark 1997 - 2009 |
Pregnant women in Denmark and their offspring during the study period (all live births). | Pregnancies with a continuous exposure to a selective serotonin reuptake inhibitor (SSRI), at least 1 month before conception until day 84 of pregnancy (last day of the first trimester). |
unexposed (general population or NOS)
Pregnancies with no exposure to a selective serotonin reuptake inhibitor (SSRI) during pregnancy. |
4183 / 843797 | Overlapping: this study included data published by Kornum 2010. Overlapping: Data related to Major and cardiac malformations not reported because an overlapping Furu 2015 a larger study including data from 5 nordic countries, including Denmark. |
| Jimenez-Solem (Controls unexposed, sick), 2012 |
Denmark 1997 - 2009 |
Pregnant women in Denmark and their offspring during the study period (all live births). | Pregnancies with a continuous exposure to a selective serotonin reuptake inhibitor (SSRI), at least 1 month before conception until day 84 of pregnancy (last day of the first trimester). |
unexposed, sick
Pregnancies with paused exposure during pregnancy (an SSRI 3-12 months before conception and 1-12 months after giving birth but with no exposure to an SSRI between 3 months before conception to 1 month after giving birth). |
4183 / 806 | Overlapping: this study included data published by Kornum 2010. Overlapping: Data related to Major and cardiac malformations not reported because an overlapping Furu 2015 a larger study including data from 5 nordic countries, including Denmark. |
| Jordan, 2016 |
Norway, Wales and Denmark. 2000 - 2010 |
All foetuses (live or still born or termination of pregnancy) and infants who 1) would have appeared in the EUROCAT registries had they been diagnosed with a major congenital anomaly, 2) had linked maternal prescription data. | Prescription of selective serotonin reuptake inhibitors (SSRIs) in the 91 days either side of the 1st day of last menstrual period (LMP). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
No prescription of selective serotonin reuptake inhibitors (SSRIs) during pregancy. |
12962 / 506155 | Number of cases and controls changed according to the considered anomaly. Overlapping: Outcomes published in Wemakor 2015 (largest study) and Given 2017 (Gastroschisis) not reported here. Overlapping: Jordan 2016 included results of Knudsen 2014. |
| Källén, 2007 |
Sweden 1995 - 2004 |
Nearly all deliveries in Sweden during the study period. | Pregnant women who reported the use of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy. |
unexposed (general population or NOS)
The total population. |
6481 / 873876 | 179 women reported the additional use of a non-SSRI antidepressant (2.8%) => >90% reported SSRI only => considered as SSRI only. Overlapping: individual malformations included in Reis 2010 not reported here. |
| Källén (Controls exposed to TCA), 2004 |
Sweden 1995 - 2001 |
All singleton children born during the study period. | Infants whose mothers received selective serotonin reuptake inhibitors (SSRIs) after the first antenatal care center visit. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants whose mothers received Tricyclic drugs after the first antenatal care center visit. (This is a subgroup of exposure among the whole exposed group considered in the study). |
558 / 395 | Overlapping: Preterm, Low birth weight, SGA, LGA; hypoglycemia, convlusions and respiratory problems not reported here because these data (Sweden 1995-2001) have been updated by larger studies: Reis 2010 (1995-2007) and Lennestal (1995-2004). |
| Källén (Controls unexposed, NOS), 2004 |
Sweden 1995 - 2001 |
All singleton children born during the study period. | Infants whose mothers received selective serotonin reuptake inhibitors (SSRIs) after the first antenatal care center visit. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All infants in the registry. |
558 / 581787 | Overlapping: Preterm, Low birth weight, SGA, LGA; hypoglycemia, convlusions and respiratory problems not reported here because these data (Sweden 1995-2001) have been updated by larger studies: Reis 2010 (1995-2007) and Lennestal (1995-2004). |
| Kieler, 2012 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2007 |
All singletons born after 231 gestational days (33 weeks). | A filled prescription of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed (general population or NOS)
No filled prescription of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
30115 / 1588140 | Overlapping: this study included results of Kallen 2008 and Norby 2016. |
| Kildegaard, 2025 |
|
-
|
-9 / -9 | Risk of disorders of gut-brain interaction in children (DGBI) (functional nausea and vomiting, functional abdominal pain disorders, functional diarrhea, and functional constipation, ...) => outcome indexed but not reported in metaPreg. | ||
| Kivistö, 2016 |
Finland 2002 - 2012 |
Women who gave birth at Kuopio University Hospital during the study period. | Pregnant women that used only Selective Serotonin Reuptake Inhibitors (SSRI) during pregnancy. |
unexposed (general population or NOS)
Pregnant women not using any antidepressant medication. |
358 / 24402 | Pre-eclampsia and Gestational diabetes not reported because not sure that exposure occurred before outcome. |
| Klieger-Grossmann - Escitalopram, 2012 |
Canada, Switzerland and Italy Not specified. |
Women who call centers for information regarding the safety of a drug, usually early in pregnancy. | Pregnant women exposed to escitalopram during pregnancy. |
unexposed (general population or NOS)
Pregnant women who called for nonteratogenic exposures such as acetaminophen, antibiotics, anti- histamines, and so on. |
213 / 212 | The 21 exposures to escitalopram that were part of a larger prospective study from Motherisk (Einarson 2009) were excluded from this study. Results versus other antidepressants (SSRIs, venlafaxine, mirtazapine...) not reported => inadequate control group. |
| Knickmeyer, 2014 |
USA Not specified |
Subjects with MRI scans at 1 and/or 2 years of age, drawn from three ongoing neuroimaging studies at University of North Carolina at Chapel Hill (UNC), one of which focuses on children exposed to SSRIs during pregnancy. | Children of mothers with depression and Selective serotonin reuptake inhibitors (SSRIs) use during pregnancy. |
unexposed, disease free
Children of mothers without Selective serotonin reuptake inhibitors (SSRIs) use during pregnancy. |
33 / 66 | 'Use of a psychiatric drug other than an SSRI was an exclusion criterion for the current analysis with the exception of trazodone, low-dose benzodiazepines, and psychostimulants.' |
| Kolding (Controls unexposed, disease free), 2021 |
Denmark 2007 - 2014 |
All clinically recognized singleton pregnancies with fetuses alive at the nuchal scan from 11 completed gestational weeks. | Pregnant women with two or more redeemed prescriptions of Selective serotonin reuptake inhibitors (SSRIs) from 28 days before through 70 days after the conception date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnant women with absence of redemptions for an antidepressant in the same time window, combined with absence of former use. |
2767 / 353581 | 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.' SSRI: Fluoxetine (N06AB03), citalopram (N06AB04), paroxetine (N06AB05), sertraline (N06AB06), fluvoxamine (N06AB08), escitalopram (N06AB10) |
| Kolding (Controls unexposed, sick), 2021 |
Denmark 2007 - 2014 |
All clinically recognized singleton pregnancies with fetuses alive at the nuchal scan from 11 completed gestational weeks. | Pregnant women with two or more redeemed prescriptions of Selective serotonin reuptake inhibitors (SSRIs) from 28 days before through 70 days after the conception date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with untreated- or well treated depression or anxiety without antidepressant use in the pregnancy (one or more redeemed prescription of an antidepressant from 365 to 183 days preconception and no redemptions between 182 days preconception through the first trimester). |
2767 / 6326 | 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.' |
| Kragholm, 2018 |
Denmark 2005 - 2008 |
All pregnancies and births in Denmark during a 4-year period. | Offspring of mothers on selective serotonin reuptake inhibitors (SSRIs) during pregnancy (from the beginning of the pregnancy to the end of the pregnancy in sensitivity analyses). |
unexposed, sick
Offspring of mothers on selective serotonin reuptake inhibitors (SSRIs) before 90 days prior to conception but not during the 90-day period before or during the actual pregnancy period. |
3314 / 3536 | |
| Kulin, 1998 |
USA and Canada Not specified. |
Pregnant women who were counseled during pregnancy. | Pregnant women who were counseled during pregnancy following exposure to a new selective serotonin reuptake inhibitors (SSRIs ; fluvoxamine, paroxetine, and sertraline) during the first trimester of pregnancy for depression. |
unexposed (general population or NOS)
Pregnant women counseled after exposure to nonteratogenic agents, randomly selected. |
267 / 267 | |
| Latendresse, 2011 |
USA March - Nov 2007 |
Singleton pregnant women recruited and enrolled from 3 community prenatal clinics who where at less than 20 weeks of gestation, at least 18 years of age, and spoke english. | Use of Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy to treat depression and/or anxiety. |
unexposed (general population or NOS)
No use of Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy. |
13 / 87 | |
| Laugesen, 2013 |
Denmark 1996 - 2009 |
All Danish singletons born alive during the study period | Children born to mother with redemption of a Selective serotonin reuptake inhibitors (SSRI) prescription by the mother 30 days prior to or during pregnancy. (This is a subgroup of exposure among the whole exposed group considered). |
unexposed (general population or NOS)
Children born to mother who had never redeemed a prescription on antidepressants. |
11721 / 816792 | |
| Lee (Controls exposed to TCAs), 2025 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals in Hong Kong between January 1, 2003 and December 31, 2018. | Women filling at least one prescription of any selective serotonin reuptake inhibitors (SSRI) only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery. |
exposed to other treatment, sick
Women filling at least one prescription of any tricyclic antidepressants (TCA) only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery. |
1465 / 613 | |
| Lee (Controls unexposed, general pop), 2024 |
Taiwan 2004 - 2016 |
All liveborn infants in Taiwan from 2004 to 2016. | Liveborn infants born to mothers who had at least one selective serotonin reuptake inhibitors (SSRIs - N06AB) dispensation during the defined periods before- and after-pregnancy and throughout pregnancy. |
unexposed (general population or NOS)
Liveborn infants born to mothers who had not received any antidepressant dispensation during the defined periods before- and after-pregnancy and throughout pregnancy. |
29739 / 2245689 | Authors provided 3 periods of exposure: 1st trimester (from 90 days before pregnancy to 90 days after conception); 2nd trimester (from conception to end of 2nd trimester)... Use of the 2nd one (larger period during pregnancy). |
| Lee (Controls unexposed, general pop), 2025 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals in Hong Kong between January 1, 2003 and December 31, 2018. | Women filling at least one prescription of any selective serotonin reuptake inhibitors (SSRI) only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery. |
unexposed (general population or NOS)
Women who were not prescribed with any antidepressant during index pregnancy. |
1465 / 463440 | |
| Lee (Controls unexposed, sibling), 2024 |
Taiwan 2004 - 2016 |
All liveborn infants in Taiwan from 2004 to 2016, with more than one child. | Liveborn infants born to mothers who had at least one selective serotonin reuptake inhibitors (SSRIs - N06AB) dispensation during the defined periods before- and after-pregnancy and throughout pregnancy. |
sibling
Siblings born to the same mother who were not exposed to antidepressants during pregnancy and antidepressant-exposed individuals. |
2458 / 2948 | Authors provided 3 periods of exposure: 1st trimester (from 90 days before pregnancy to 90 days after conception); 2nd trimester (from conception to end of 2nd trimester)... Use of the 2nd one (larger period during pregnancy). |
| Lennestal, 2007 |
Sweden 1995 - 2004 |
Nearly all pregnant women in Sweden during the study period. | Women who reported the use of Selective serotonin reuptake inhibitor (SSRI) drugs during pregnancy (early and/or late pregnancy). |
unexposed (general population or NOS)
All deliveries in the register. |
-9 / 873876 | Methods completed with publication of Kallen 2007 because authors mentioned that 'Data for SSRI from Kallen 2007'. Malfo, LBW, preterm, SGA, LGA: overlapping with Kallen 2007 and Reis 2010 (1995 - 2007). |
| Levinson-Castiel, 2006 |
Israel 2002 - 2004 |
Neonates born in the tertiary care center. | Neonates exposed to selective serotonin reuptake inhibitors (SSRIs) in utero during the entire pregnancy or at least during the third trimester. |
unexposed, disease free
Neonates not exposed to selective serotonin reuptake inhibitors (SSRIs) in utero, born to healthy mothers. |
60 / 60 | Maternal intake of SSRIs during pregnancy, including fluoxetine, paroxetine, citalopram, sertraline, and the serotonin-noradrenaline reuptake inhibitor venlafaxine. Of the 60 exposed pregnancies, only 2 exposed to venlafaxine (3.3%) => considered as SSRI. |
| Levy, 2020 |
Israel Jan - June 2019 |
All women who gave birth at 24–42 weeks to a singleton neonate and that had a full placental histopathology-report. | Maternal Selective Serotonin Reuptake Inhibitors (SSRIs) use throughout pregnancy. |
unexposed (general population or NOS)
No Maternal Selective Serotonin Reuptake Inhibitors (SSRIs) use during pregnancy. |
82 / 82 | |
| Liu, 2017 |
Denmark 1998 - 2012 |
All liveborn singletons during the study period. | A prescription of Selective serotonin reuptake inhibitors (SSRIs) monotherapy dispensed on any date from one month before pregnancy until delivery. (This is a subgroup of exposure among the whole exposed group considered). |
unexposed, sick
Antidepressant discontinuation (use before but not during pregnancy). |
16154 / 30079 | For emotional disorders: Overlapping: Liu 2017 (1998 - 2012) included in Bliddal 2023 (1997 - 2015) => Only Bliddal 2023 used here because more exposed pregnancies. For ASD: use of Liu 2017 rather Sorensen 2013 (more pregnancies in Liu 2017). |
| Liu, 2015 |
Denmark 1996 - 2007 |
All live singletons born in Denmark during the study period. | Children born to mothers who had prenatal depression and who used Selective serotonin reuptake inhibitors (SSRIs) only during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to mothers who had prenatal depression and who did not take antidepressants during pregnancy. |
7186 / 12476 | Selective serotonin reuptake inhibitors (SSRIs, fluoxetine, citalopram, escitalopram, paroxetine, sertraline, and fluvoxamine [N06AB03-10]). |
| Lund (Controls unexposed, disease free), 2009 |
Denmark 1989 - 2006 |
Singleton pregnancies receiving prenatal care in this hospital during the study period. | Pregnant women reported treatment with selective serotonin reuptake inhibitor (SSRIs) during pregnancy. |
unexposed, disease free
Pregnant women without a history of psychiatric illness. |
329 / 51770 | Among the 329 women with SSRI intake, 38 (88%) also used another psychotropic drug during pregnancy. |
| Lund (Controls unexposed, sick), 2009 |
Denmark 1989 - 2006 |
Singleton pregnancies receiving prenatal care in this hospital during the study period. | Pregnant women reported treatment with selective serotonin reuptake inhibitor (SSRIs) during pregnancy. |
unexposed, sick
Pregnant women who were not treated with selective serotonin reuptake inhibitor (SSRIs) but had a history of psychiatric illness. |
329 / 4902 | Among the 329 women with SSRI intake, 38 (88%) also used another psychotropic drug during pregnancy. |
| Lupattelli (Controls exposed to TCA), 2017 |
Norway 1999 - 2008 |
Depressed pregnant women recruited from all over Norway through a postal invitation in connection with a routine ultrasound at gestational weeks (GWs) 17 and 18. | Depressed pregnant women that reported use of selective serotonin reuptake inhibitors (SSRIs) monotherapy during pregnancy. |
exposed to other treatment, sick
Depressed pregnant women that reported use of tricyclic antidepressants (TCAs) monotherapy during pregnancy. |
654 / 21 | 'Women on antidepressant polytherapy, ie, exposed to multiple antidepressant groups in pregnancy, were excluded' |
| Lupattelli (Controls unexposed, disease free), 2014 |
Norway 1999 - 2006 |
Singleton pregnant women recruited through a postal invitation in connection with the routine ultrasound examination offered to all pregnant women at 17 to 18 weeks of gestation. | Use of Selective serotonin reuptake inhibitors (SSRIs) or Serotonin–norepinephrine reuptake inhibitors (SNRIs) during pregnancy. |
unexposed, disease free
No reported use of antidepressants during pregnancy and no presence of depressive symptoms at gestational weeks 17 and/or 30. |
527 / 55411 | Venlafaxine and duloxetine represents less than 10% (11/123) of the SSRI/SNRI exposures during last part of pregnancy=> Considered as SSRI exposure. |
| Lupattelli (Controls unexposed, sick), 2017 |
Norway 1999 - 2008 |
Depressed pregnant women recruited from all over Norway through a postal invitation in connection with a routine ultrasound at gestational weeks (GWs) 17 and 18. | Depressed pregnant women that reported use of selective serotonin reuptake inhibitors (SSRIs) monotherapy during pregnancy. |
unexposed, sick
Depressed pregnant women nonmedicated. |
654 / 5106 | 'Women on antidepressant polytherapy, ie, exposed to multiple antidepressant groups in pregnancy, were excluded' |
| Lupattelli (Controls unexposed, sick), 2014 |
Norway 1999 - 2006 |
Singleton pregnant women recruited through a postal invitation in connection with the routine ultrasound examination offered to all pregnant women at 17 to 18 weeks of gestation. | Use of Selective serotonin reuptake inhibitors (SSRIs) or Serotonin–norepinephrine reuptake inhibitors (SNRIs) during pregnancy. |
unexposed, sick
No exposure to antidepressants but presence of depressive symptoms at both gestational weeks 17 and 30. |
527 / 1282 | Venlafaxine and duloxetine represents less than 10% (11/123) of the SSRI/SNRI exposures during last part of pregnancy=> Considered as SSRI exposure. |
| Lyn, 2023 |
Australia 2020 - 2021 |
Patients who delivered at a non-for-profit private hospital during the study period. | Pregnant women who reported selective serotonin reuptake inhibitor (SSRI) use in their pregnancy. |
unexposed (general population or NOS)
Pregnant women who did not report antidepressant use in their pregnancy. |
130 / 259 | Sertraline is the most common SSRI used in pregnancy (56%). |
| Malm, 2011 |
Finland 1996 - 2006 |
All the Finnish births and terminations attributable to severe fetal anomalies during the study period. | Offspring of mothers with at least one purchase of one or more selective serotonin reuptake inhibitor drugs during the period of 1 month before pregnancy and first trimester. |
unexposed (general population or NOS)
Offspring of mothers without purchase of one or more selective serotonin reuptake inhibitor drugs. |
6881 / 618727 | Overlapping: Major malformations and cardiovascular malformations (excepted ASV, VSD and transpo of great vessels) updated in a larger study published by Furu 2015 (1996-2010). Thus only the not updated malformations are reported here. |
| Malm (Controls unexposed, disease free), 2015 |
Finland 1996 - 2010 |
All singleton live births in Finland during the study period. | Pregnant women who purchased selective serotonin reuptake inhibitors (SSRIs) during the period from 30 days before the beginning of gestation until the end of pregnancy. |
unexposed, disease free
Pregnant women who had no psychiatric diagnosis and no exposure to selective serotonin reuptake inhibitors (SSRIs). |
15729 / 31394 | Overlapping: Data related to PPHN and Major malformations not reported because an overlapping with Kieler 2012 and Furu 2015, 2 larger studies including data from 5 nordic countries, including Finland. Overlapping: Malm 2015 included Malm 2005. |
| Malm (Controls unexposed, disease free), 2016 |
Finland 1996 - 2010 |
Singleton live births during the study period. | Pregnant women who had one or more purchases of Selective serotonin reuptake inhibitors (SSRIs) during the period from 30 days before pregnancy until the end of pregnancy. |
unexposed, disease free
Pregnant women with neither purchases of antidepressants nor antipsychotics, and no depression or related psychiatric disorder at any time prior to or during pregnancy. |
15729 / 31394 | |
| Malm (Controls unexposed, sick), 2015 |
Finland 1996 - 2010 |
All singleton live births in Finland during the study period. | Pregnant women who purchased selective serotonin reuptake inhibitors (SSRIs) during the period from 30 days before the beginning of gestation until the end of pregnancy. |
unexposed, sick
Pregnant women who had a psychiatric diagnosis related to SSRIs but who had no purchases of antidepressants or antipsychotics from 3 months before the beginning of gestation until delivery. |
15729 / 9652 | Overlapping: Data related to PPHN and Major malformations not reported because an overlapping with Kieler 2012 and Furu 2015, 2 larger studies including data from 5 nordic countries, including Finland. Overlapping: Malm 2015 included Malm 2005. |
| Malm (Controls unexposed, sick), 2016 |
Finland 1996 - 2010 |
Singleton live births during the study period. | Pregnant women who had one or more purchases of Selective serotonin reuptake inhibitors (SSRIs) during the period from 30 days before pregnancy until the end of pregnancy. |
unexposed, sick
Pregnant women who had a diagnosis of depression or other psychiatric disorder, from one year before pregnancy until discharge (≤ 3 weeks) from hospital after delivery, and no purchases of antidepressants or antipsychotics from three months before until the end of pregnancy. |
15729 / 9651 | |
| Man (Controls exposed to antipsychotics), 2017 |
Hong Kong 2001 - 2009 |
All children born in public hospitals in Hong Kong. | Children whose mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children whose mothers used antipsychotics (non SSRIs users) during pregnancy. |
425 / -9 | Number of children exposed to SSRI considered not clearly stated (425 SSRI only and/or 266 SSRI in combination). Number of children exposed to antipsychotics (non SSRIs users) not provided. |
| Man (Controls unexposed, NOS), 2017 |
Hong Kong 2001 - 2009 |
All children live born in public hospitals in Hong Kong during the study period. | Children whose mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children of mothers who were non-gestational users (a combined group of never users and preconception users). |
691 / 189002 | The non-gestational users marginally composed of mothers that had discontinued treatment before pregnancy (n=1486). Number of children exposed to SSRI considered not clearly stated (425 SSRI only and/or 266 SSRI in combination). |
| Manakova, 2011 |
Czech Republic 2002 - 2009 |
Pregnant women, who contacted (on their own initiative or through their health-care providers), the Czech Teratology Information Service (CZTIS), until 16 week of pregnancy. | Pregnant women exposed to Selective serotonin reuptake inhibitors (SSRI). |
unexposed (general population or NOS)
Pregnant women exposed to non-teratogenic and non-psychotropic substances (mainly to hormonal contraception, common antibiotics, vaccine, paracetamol or antihistaminics). |
43 / 85 | 'Ten cases were included in both groups exposed to both, SSRI and APD (new psychotropic drugs).' |
| Margulis, 2013 |
United Kingdom 1996 - 2010 |
All singletons in the Mother–Baby Link delivered during the study period with delivery and birth dates within 2 months of each other. | Pregnant women who had one or more therapy episodes for Selective serotonin reuptake inhibitor (SSRIs) overlapping with the first trimester of pregnancy and did not have therapy episodes for other antidepressants. |
unexposed (general population or NOS)
Pregnant women with no antidepressant therapy episodes in the 3 months before pregnancy or in the first or second trimester of pregnancy. |
3046 / 8991 | Primary outcomes: cardiac malformations at 1 year. Thus results at 6 years not reported here. |
| Marks - Sertraline (Controls exposed to Bupropion), 2021 |
USA 2010 - 2019 |
Women who received at least one antidepressant prescription 3 months prior to conception through delivery. | Pregnant women with one (or more) prescription of Sertraline written during the time period studied. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women with one (or more) prescription of Bupropion written during the time period studied. |
1653 / 406 | This study assessed several SSRIs => data of all SSRI substances cannot be added (to keep adjustment). Thus, in order to avoid redundancy of control, only the substance with the higher number of exposure was used in the meta-analysis (i.e sertraline). |
| Marks - Sertraline (Controls unexposed, sick), 2021 |
USA 2010 - 2019 |
Women who received at least one antidepressant prescription 3 months prior to conception through delivery. | Pregnant women with one (or more) prescription of Sertraline during the third trimester exposure. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women who took an antidepressant at some point during pregnancy but did not have a prescription for any antidepressant during the relevant period of exposure. |
883 / -9 | This study assessed several SSRIs => data of all SSRI substances cannot be added (to keep adjustment). Thus, in order to avoid redundancy of control, only the substance with the higher number of exposure was used in the meta-analysis (i.e sertraline). |
| Martin - Sertraline, 2024 |
Norway, Sweden and United Kingdom. 1996 - 2020 |
Singleton deliveries 22 weeks’ completed gestational weeks registered in the different databases during the study periods (UK: 1996-2018, Norway: 2009-2020, Sweden: 2006-2020). | Singleton deliveries with maternal sertraline (without concurrent prescriptions for different antidepressants) use during pregnancy proxied by prescriptions in the United Kingdom and dispensations in Norway and Sweden. |
unexposed (general population or NOS)
Singleton deliveries without maternal antidepressants use during pregnancy proxied by prescriptions in the United Kingdom and dispensations in Norway and Sweden. |
34604 / 2408707 | Overlapping: For SGA, Apgar and Preterm: Martin 2024 totally included Norby 2016 (2006-2012) and Skalkidou 2020 (2013-2017) for preterm only => Martin 2024 used because more pregnancies and adjustments. |
| Maschi - Fluoxetine, 2008 |
Italy 1995 - 2003 |
Pregnant women who called the Drug and Health Information Centre at the ‘Mario Negri’ Institute. | Women who took Fluoxetine during pregnancy and delivered liveborn children. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who were counselled at the Centre on the use of nonteratogenic drugs or drugs that do not cause neonatal adverse effects, such as antibiotics or paracetamol. |
32 / 192 | 'In all, 33 women (17%) had taken more than one antidepressant drug and 86 (43%) had received these medications in combination with a benzodiazepine.' Not the same women in the control group for paroxetine and fluoxetine. |
| Maschi - Paroxetine, 2008 |
Italy 1995 - 2003 |
Pregnant women who called the Drug and Health Information Centre at the ‘Mario Negri’ Institute. | Women who took Paroxetine during pregnancy and delivered liveborn children. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who were counselled at the Centre on the use of nonteratogenic drugs or drugs that do not cause neonatal adverse effects, such as antibiotics or paracetamol. |
58 / 348 | 'In all, 33 women (17%) had taken more than one antidepressant drug and 86 (43%) had received these medications in combination with a benzodiazepine.' Not the same women in the control group for paroxetine and fluoxetine. |
| Merlob, 2009 |
Israel 2000 - 2007 |
Pregnant women who gave birth at the tertiary center | Pregnant women who reported using Selective serotonin reuptake inhibitors (SSRIs) during the first trimester. |
unexposed (general population or NOS)
Pregnant women who not reported using Selective serotonin reuptake inhibitors (SSRIs). |
235 / 67636 | 'Any infant with multiple congenital anomalies or dysmorphic features underwent genetic evaluation by a trained expert to exclude a congenital syndrome.' |
| Misri, 2006 |
Canada 1997 - 1999 |
Children of pregnant women recruited from the Reproductive Mental Health Program and from pediatricians’ offices. | Children of depressed/anxious mothers exposed to selective serotonin reuptake inhibitor (SSRI) only during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children of healthy, nondepressed, and nonmedicated mothers. |
13 / 14 | Overlapping of some outcomes (Clinician ratings - the Crowell procedure) at 4-5 years old) with Oberlander 2007 which include a little more pregnancies, thus these outcomes not reported for Misri 2006. |
| Morimoto, 2021 |
Japan 2010 - 2019 |
Neonates born at Okayama University Hospital whose mothers had been taking antipsychotics, antidepressants, sedatives, or anticonvulsants. | Use of selective serotonin reuptake inhibitors (SSRIs) continued before or during pregnancy until just before delivery. |
exposed to other treatment, sick
No use of selective serotonin reuptake inhibitors (SSRIs) (but mothers exposed to antipsychotics, antidepressants, sedatives, or anticonvulsants). |
33 / 126 | |
| Mulder, 2011 |
The Netherlands Not specified. |
Pregnant women identified by physicians or midwives at participating sites and approached by the study coordinator (FFTV). | Fetuses exposed to Selective serotonin reuptake inhibitors (SSRIs) throughout pregnancy |
unexposed, disease free
Unexposed fetuses (no SSRI at study entry and during the remainder of their pregnancy) of healthy women with no history of psychiatric or other illnesses. |
96 / 130 | The majority used paroxetine (44%), 21% used fluoxetine (type 2), 20% used citalopram (type 3), 7% used venlafaxine, 4% used fluvoxamine, and 4% took sertraline. |
| Nielsen, 2017 |
Denmark 1996 - 2016 |
All live born children identified by the Medical Birth Registry with a valid civil registration in Denmark. | All children of women who had filled one or more prescriptions of Selective serotonin reuptake inhibitors (SSRIs) from 30 days before conception to end of first trimester (end of 12th week of pregnancy).. |
unexposed (general population or NOS)
All children that mothers did not fill prescriptions of Selective serotonin reuptake inhibitors (SSRIs) from 30 days before conception to end of first trimester. |
19807 / 1236510 | |
| Nijenhuis (Controls exposed to TCA), 2012 |
The Netherlands 1995 - 2009 |
Children selected by date of birth (between 1995 - 2009) and the female person (15–50 years) with the same address code (considered to be the mother). | Children of mothers exposed to selective serotonin re-uptake inhibitors (SSRIs) during pregnancy. |
exposed to other treatment, sick
Children of mothers exposed to tricyclic antidepressants (TCAs) during pregnancy. |
527 / 76 | The group exposed to both a SSRI and a TCA was excluded from the TCA exposed group and SSRI exposed group. SSRI: Paroxetine (n = 310), fluoxetine (n = 105), citalopram (n = 60), fluvoxamine (n = 60), sertraline (n = 19), escitalopram (n = 2). |
| Nijenhuis (Controls unexposed, NOS), 2012 |
The Netherlands 1995 - 2009 |
Children selected by date of birth (between 1995 - 2009) and the female person (15–50 years) with the same address code (considered to be the mother). | Children of mothers exposed to selective serotonin re-uptake inhibitors (SSRIs) during pregnancy. |
unexposed (general population or NOS)
Children of mothers who did not use any selective serotonin re-uptake inhibitors (SSRIs) or tricyclic antidepressants (TCAs) during pregnancy and during a period of 7 days before pregnancy. |
527 / 34908 | The group exposed to both a SSRI and a TCA was excluded from the TCA exposed group and SSRI exposed group. SSRI: Paroxetine (n = 310), fluoxetine (n = 105), citalopram (n = 60), fluvoxamine (n = 60), sertraline (n = 19), escitalopram (n = 2). |
| Nishigori, 2017 |
Japan 2011 - 2014 |
Pregnant women recruited through the 15 Regional Centers who had participated in both interviews. | Any Selective serotonin reuptake inhibitors (SSRI) use, up to the 12th gestational week. |
unexposed (general population or NOS)
No Selective serotonin reuptake inhibitors (SSRI) use before and during pregnancy. |
172 / 95433 | |
| Norby, 2016 |
Sweden 2006 - 2012 |
All singleton births in Sweden during the study period. | Infants of mothers who used selective serotonin reuptake inhibitors (SSRIs) during pregnancy (at any time during or 1 month before the pregnancy). |
unexposed (general population or NOS)
No antidepressant use during pregnancy. |
17736 / 718533 | Overlapping: Malformations not reported because overlapping with Furu 2015: larger study (including Sweden). For preterm, SGA and Apgar: Martin 2024 used rather than Norby 2016 or Sujan 2017 (less expo/adjustments). |
| Nordeng (Controls unexposed, NOS), 2012 |
Norway 2000 - 2006 |
All women who gave birth in Norway, recruited into at the routine ultrasound examination in gestational weeks 17 to 18. Multiple births as well as infants with chromosomal abnormalities were excluded from the analyses. | Exposure to selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
No reported use of any antidepressants in the 6 months before or during pregnancy. |
572 / 61648 | Little overlapping between Nordeng 2012 (2000 - 2006) and Furu 2015 (including Norway 2005-10) => the 2 studies kept. |
| Nordeng (Controls unexposed, sick), 2012 |
Norway 2000 - 2006 |
All women who gave birth in Norway, recruited into at the routine ultrasound examination in gestational weeks 17 to 18. Multiple births as well as infants with chromosomal abnormalities were excluded from the analyses. | Exposure to selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies that reported use of an antidepressant during the 6 months before pregnancy, but not during pregnancy. |
572 / 1048 | Little overlapping between Nordeng 2012 (2000 - 2006) and Furu 2015 (including Norway 2005-10) => the 2 studies kept. |
| Nulman (Controls unexposed, disease free), 2012 |
Canada 2001 - 2006 |
Pregnant women who sought counseling on the pregnancy safety of medications. (This is a subgroup of exposure among the whole exposed group considered in the study). | Depressed women who took selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, disease free
Nondepressed, healthy pregnant women who called Motherisk to inquire about nonteratogenic exposure (e.g., acetaminophen). |
62 / 62 | 'Excluded were mothers exposed to polytherapy for depression or known teratogens, mothers with substance abuse, mothers with other psychiatric conditions, prematurity, mothers and/or children with medical conditions that may affect cognitive outcomes.' |
| Nulman (Controls unexposed, sick), 2012 |
Canada 2001 - 2006 |
Pregnant women who sought counseling on the pregnancy safety of medications. (This is a subgroup of exposure among the whole exposed group considered in the study). | Depressed women who took selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed, sick
Depressed women who were untreated during pregnancy (discontinued pharmacotherapy before conception). |
62 / 54 | 'Excluded were mothers exposed to polytherapy for depression or known teratogens, mothers with substance abuse, mothers with other psychiatric conditions, prematurity, mothers and/or children with medical conditions that may affect cognitive outcomes.' |
| Nulman - Fluoxetine (Controls exposed to TCA), 1997 |
Canada Since 1985 |
Pregnant women counseled by the program. | Pregnant women who took fluoxetine at least during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women who took a tricyclic antidepressant drug at least during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
55 / 80 | Overlapping of some outcomes (language development) with Nulman 2002 (with more relevant period of exposure), thus not reported here. For Cognitive Index: the nb of infants examined by Bayley or McCarthy scales not provided. => data not extractable. |
| Nulman - Fluoxetine (Controls exposed to TCA), 2002 |
Canada Until 1985 |
Mothers were approached during the first trimester of pregnancy when contact was made with Motherisk to provide information and consultation on the risk/safety of drug. | Pregnant women diagnosed as having major depression who had been counseled by the program regarding therapy with fluoxetine and who had continued taking these medications throughout gestation. |
exposed to other treatment, sick
Pregnant women diagnosed as having major depression who had been counseled by the program regarding therapy with tricyclic antidepressants and who had continued taking these medications throughout gestation. |
40 / 46 | 'Eighteen mother-child pairs exposed to fluoxetine and 36 exposed to tricyclic antidepressants who were part of our original study (Nulman 1997) and who were exposed to these drugs throughout gestation were included in the present study.' |
| Nulman - Fluoxetine (Controls unexposed, disease free), 2002 |
Canada Until 1985 |
Mothers were approached during the first trimester of pregnancy when contact was made with Motherisk to provide information and consultation on the risk/safety of drug. | Pregnant women diagnosed as having major depression who had been counseled by the program regarding therapy with fluoxetine and who had continued taking these medications throughout gestation. |
unexposed, disease free
Pregnant women who had no history of a psychiatric disorder or depressive symptoms and were unexposed to any drug, chemical, radiation, or infection known to affect the fetus adversely. |
40 / 36 | 'Eighteen mother-child pairs exposed to fluoxetine and 36 exposed to tricyclic antidepressants who were part of our original study (Nulman 1997) and who were exposed to these drugs throughout gestation were included in the present study.' |
| Nulman - Fluoxetine (Controls unexposed, NOS), 1997 |
Canada Since 1985 |
Pregnant women counseled by the program. | Pregnant women who took fluoxetine at least during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women not exposed to any drug, chemical, radiation, or infection known to affect the fetus adversely. |
55 / 84 | Overlapping of some outcomes (language development) with Nulman 2002 (with more relevant period of exposure), thus not reported here. For Cognitive Index: the nb of infants examined by Bayley or McCarthy scales not provided. => data not extractable. |
| Oberlander, 2004 |
Canada 1996 - 2000 |
Mothers and their infants studied during pregnancy as a part of a larger study of the effects of psychotropic medication use during and following pregnancy. | Infants prenatally exposed to Selective serotonin reuptake inhibitors (SSRIs) alone. |
unexposed, disease free
Term-born healthy infants whose mother did not use psychotropic or antidepressant medications during pregnancy and without history of maternal mental illness. |
28 / 23 | Overlapping between Hutchison 2019a (not specified study period - 6 years old) and Oberlander 2004 (1996 - 2000 - 8 months old) => not assessable but probably low because each study is a small sample of the larger study. |
| Oberlander, 2007 |
Canada 1997 - 1999 |
A consecutive cohort of mothers and their infants were recruited during pregnancy as part of a prospective longitudinal study of prenatal psychotropic medication use. | Children prenatally exposed to Selective Serotonin Reuptake Inhibitor (SSRIs). |
unexposed, disease free
Children of mothers without psychotropic, illicit drug use or antidepressant medication use during the pregnancy and without history of maternal mental illness. |
22 / 14 | Overlapping of some outcomes (Mental and Psychomotor Development Index) with Oberlander 2004 which include a little more pregnancies, thus these outcomes not reported for Oberlander 2007 (which focuses on Externalizing disorders). |
| Oberlander a, 2008 |
Canada 1997 - 2002 |
About (92.7%) all live births (hospital and home births) in British Columbia during the study period. | Infants exposed to serotonin reuptake inhibitor (SRI) monotherapy in the first trimester of pregnancy. |
unexposed (general population or NOS)
Infants with no exposure to either of these drugs (SRI or benzodiazepine) in the first trimester of pregnancy. |
2625 / 107320 | Serotonin reuptake inhibitor (SRI) includes SSRI and venlafaxine (7.1%). Because the rate of SSRI is above 90%, SRI are mainly represented by SSRI, and can be used as SSRI group. |
| Olstad - (Es)citalopram (Controls unexposed, disease free), 2023 |
Norway 1998 - 2008 |
Singleton births born in Norway during the study period, with cord blood samples available in the MoBa biobank. | Singleton births with prenatal (es)citalopram exposure, defined as reported use at any time during pregnancy. |
unexposed, disease free
Singleton births unexposed prenatally to antidepressants and maternal depression (self reported by mother). |
306 / 344 | In the (es)citalopram group, other antidepressants were allowed, except when used concomitantly with (es)citalopram on the same indication. The indications for (es)citalopram were depression, anxiety, and other mental health problems. |
| Olstad - (Es)citalopram (Controls unexposed, sick), 2023 |
Norway 1998 - 2008 |
Singleton births born in Norway during the study period, with cord blood samples available in the MoBa biobank. | Singleton births with prenatal (es)citalopram exposure, defined as reported use at any time during pregnancy. |
unexposed, sick
Singleton births prenatally exposed to maternal depression (self reported by mother). |
306 / 308 | In the (es)citalopram group, other antidepressants were allowed, except when used concomitantly with (es)citalopram on the same indication. The indications for (es)citalopram were depression, anxiety, and other mental health problems. |
| Ozturk - Escitalopram, 2016 |
Turkey 2007 - 2012 |
Pregnant women referred to the prenatal consultation service for psychotropic drug exposure. | Pregnant women exposed to Escitalopram during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women selected from the non-teratogen exposed pregnancies in the same year. |
35 / 275 | This study assessed several SSRIs, with potential co-exposures => data of all SSRI substances cannot be added. To avoid redundancy of control, only the substance with the higher number of exposure was used in the meta-analysis (i.e escitalopram). |
| Palmsten, 2020 |
USA 2012 - 2016 |
Singleton liveborn deliveries among females ages 12-49 using delivery-related diagnosis and procedure codes. | Pregnant women with dispensation of selective serotonin reuptake inhibitor antidepressants (SSRIs) monotherapy during different trajectories of exposure. (This is a subgroup of exposure among the whole exposed group considered in the study). Exposed group: addition of trajectories B, D and E. |
unexposed, sick
Pregnant women with a depression diagnosis (during the relevant exposure period) without antidepressant dispensings. |
3804 / 4949 | Exposed group: addition of trajectories B, D and E. Unexposed group: depression group was used (rather than anxiety group) to better reflect confounding by indication. |
| Palmsten (control exposed to TCA), 2013 |
USA 2000 - 2007 |
Pregnant women with a depression diagnosis enrolled in Medicaid. | Pregnant women with a depression diagnosis and a dispensation of selective serotonin reuptake inhibitor (SSRI) in monotherapy during the exposure window. |
exposed to other treatment, sick
Pregnant women with a depression diagnosis and a dispensation of tricyclic antidepressant in monotherapy during the exposure window. |
19000 / 441 | Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy. |
| Palmsten (Controls exposed to TCA), 2012 |
Canada 1997 - 2006 |
Pregnancies that ended in a livebirth in women with at least 1 inpatient or outpatient code for depression during the year prior to the last menstrual period until 20 completed gestational weeks. | Pregnant women with at least 1 pharmacy dispensing record for a selective serotonin reuptake inhibitor (SSRI) during estimated gestational weeks 10–20 (Monotherapy). |
exposed to other treatment, sick
Pregnant women with at least 1 pharmacy dispensing record for a tricyclic antidepressant during estimated gestational weeks 10–20 (Monotherapy). |
3169 / 146 | 'Exposure was classified as monotherapy if dispensings for only 1 antidepressant class were present during pregnancy and as polytherapy otherwise.' |
| Palmsten (Controls unexposed, sick), 2013 |
USA 2000 - 2007 |
Pregnant women with a depression diagnosis enrolled in Medicaid. | Pregnant women with a depression diagnosis and a dispensation of selective serotonin reuptake inhibitor (SSRI) in monotherapy during the exposure window. |
unexposed, sick
Pregnant women with a depression diagnosis and no antidepressant exposure between the LMP and the end of the exposure window. |
19000 / 59219 | Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy. |
| Palmsten (Controls unexposed, sick), 2012 |
Canada 1997 - 2006 |
Pregnancies that ended in a livebirth in women with at least 1 inpatient or outpatient code for depression during the year prior to the last menstrual period until 20 completed gestational weeks. | Pregnant women with at least 1 pharmacy dispensing record for a selective serotonin reuptake inhibitor (SSRI) during estimated gestational weeks 10–20 (Monotherapy). |
unexposed, sick
Pregnant women with no antidepressant dispensings between the year prior to the last menstrual period and gestational week 20. |
3169 / 65392 | 'Exposure was classified as monotherapy if dispensings for only 1 antidepressant class were present during pregnancy and as polytherapy otherwise.' |
| Palmsten b, 2013 |
USA 2000 - 2007 |
Subcohort of pregnancies in women with diagnoses for mood or anxiety disorders (between one and five months before delivery), ending in live birth among women aged 12-55. | Women with a supply of Selective serotonin reuptake inhibitor (SSRIs) monotherapy that overlapped with the delivery date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Women who had no supply of antidepressants in the five months before delivery. |
11516 / 69044 | Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery. |
| Pastuszak - Fluoxetine (Controls exposed to TCA), 1993 |
USA and Canada Not specified |
All cases of women contacting one of the above Teratogen Information Services (TIS) during pregnancy. | Pregnant women exposed to fluoxetine during the first trimester. |
exposed to other treatment, sick
Pregnant women exposed to tricyclic antidepressants (TCAs) during the first trimester. |
74 / 74 | The matched cohort was considered. Authors made comparison Fluoxetine versus TCAs, thus considered as mono-exposure. |
| Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 |
USA and Canada Not specified |
All cases of women contacting one of the above Teratogen Information Services (TIS) during pregnancy. | Pregnant women exposed to fluoxetine during the first trimester. |
unexposed (general population or NOS)
Pregnant women who sought counseling at Motherisk regarding exposure to a nonteratogen. |
128 / 128 | Authors made comparison Fluoxetine versus TCAs, thus considered as mono-exposure. |
| Pearson (Controls exposed to TCA), 2007 |
USA 1996 - 2000 |
Infants whose mothers Massachusetts General Hospital (MGH). | Infants whose mothers with primary major affective or anxiety disorders used serotonin reuptake inhibitor (SRIs) during any portion of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants whose mothers with primary major affective or anxiety disorders used Tricyclic antidepressants (TCAs) during any portion of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
42 / 37 | SRI: fluoxetine (N = 17), sertraline (N = 13), paroxetine (N = 12). TCA: nortriptyline (N = 13), imipramine (N = 11), desipramine (N = 7), clomipramine (N = 4), amitriptyline (N = 2). |
| Pearson (Controls unexposed, NOS), 2007 |
USA 1996 - 2000 |
Infants whose mothers Massachusetts General Hospital (MGH). | Infants whose mothers with primary major affective or anxiety disorders used serotonin reuptake inhibitor (SRIs) during any portion of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants whose mothers were not exposed to an antidepressant drug during pregnancy. |
42 / 168 | SRI: fluoxetine (N = 17), sertraline (N = 13), paroxetine (N = 12). |
| Pedersen, 2010 |
Denmark 1996 - 2002 |
Recruitment among danish pregnant women by about 50% of general practitioners nationwide. | Live-born singletons of pregnant women that reported use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Live-born singletons of pregnant women depressed during pregnancy but did not report use of any psychotropic medication (untreated depression). |
-9 / 479 | Among the 415 women treated with antidepressants, 336 used 1 type of SSRI only, 12 used >1 SSRI, 28 used only TCAs, and 29 used other types of antidepressants only (eg, venlafaxine). Ten used combinations of SSRIs, TCAs, and other antidepressants. |
| Rai (Controls exposed to TCA), 2017 |
Sweden 2001 - 2011 |
All young people aged 0 to 17 years, residing in Stockholm County between 2001 and 2011. | Children of mothers who used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children of mothers who used Clomipramine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
2710 / 235 | Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy. |
| Rai (Controls unexposed, disease free), 2017 |
Sweden 2001 - 2011 |
All young people aged 0 to 17 years, residing in Stockholm County between 2001 and 2011. | Children of mothers who used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
No maternal psychiatric disorder and unexposed to antidepressants |
2710 / 238943 | Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy. |
| Rai (Controls unexposed, sick), 2017 |
Sweden 2001 - 2011 |
All young people aged 0 to 17 years, residing in Stockholm County between 2001 and 2011. | Children of mothers who used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of mothers with psychiatric disorders (any time before the birth of the child) who did not take antidepressants during pregnancy. |
2710 / 12325 | Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy. |
| Rampono, 2009 |
Australia Not specified. |
Pregnant women recruited prospectively and opportunistically (18–32 weeks of pregnancy) from the outpatient clinics. | Pregnant patients treated with Selective serotonin reuptake inhibitor (SSRI) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women untreated with antidepressants during pregnancy. |
27 / 18 | Maternal antenatal EPDS scores were not different between cases and controls. Mothers who were known substance abusers, or who took any medication known to alter infant behaviour (apart from those being investigated) were excluded from the study. |
| Raviv, 2025 |
Israel 2011 - 2022 |
Infant-mother dyads of liveborn infants delivered at Lis Maternity and Women’s Hospital, Tel Aviv Sourasky Medical Center (TASMC), between January 1, 2011, and January 1, 2022. | Infants born at term with gestational Selective serotonin reuptake inhibitors (SSRI) treatment. |
unexposed (general population or NOS)
Infants born at term from the general population. |
2321 / 103607 | |
| Reebye, 2002 |
Canada 1997 - 1999 |
Expectant mothers undergoing psychiatric treatment in the Department of Reproductive Psychiatry, Children’s and Women’s Health Centre; and from pediatricians’ offices (control). | Depressed mothers receiving Selective serotonin reuptake inhibitors (SSRI) alone during pregnancy. |
unexposed, disease free
Nondepressed (clinically and by self-report), nontreated (psychotropic medications) healthy (no other serious comorbid pathology) mothers and their healthy infants (living with biological mothers). |
24 / 23 | Overlapping: Some outcomes (Mental and Psychomotor Development Index) also reported by Oberlander 2004 which include a little more pregnancies, thus these outcomes not reported for Reebye 2002. |
| Reis (Controls exposed to TCA), 2010 |
Sweden 1995 - 2007 |
Almost all deliveries in Sweden (1–2% missing). | Pregnant women who reported the use of selective serotonin receptor inhibitors (SSRIs) in early or late pregnancy or were prescribed SSRIs during pregnancy. |
exposed to other treatment, sick
Pregnant women who reported the use of tricyclic antidepressants (TCAs) in early or late pregnancy or were prescribed TCAs during pregnancy. |
10170 / 1662 | For preterm and SGA: overlapping Reis 2010 (95-07); Norby (06-12) and Sujan 2017 (96-12): Reis and Norby (more exposures). |
| Reis (Controls unexposed, NOS), 2010 |
Sweden 1995 - 2007 |
Almost all deliveries in Sweden (1–2% missing). | Pregnant women who reported the use of selective serotonin receptor inhibitors (SSRIs) in early or late pregnancy or were prescribed SSRIs during pregnancy. |
unexposed (general population or NOS)
All other pregnant women in the register (not exposed to antidepressants during pregnancy). |
10170 / 1062190 | For preterm and SGA: overlapping Reis 2010 (95-07); Norby (06-12) and Sujan 2017 (96-12): Reis and Norby (more exposures). |
| Richardson, 2019 |
United Kingdom 1995 - 2018 |
Pregnancies for which healthcare professionals contacted the UKTIS to discuss the potential fetal effects of maternal environmental exposures (medicines/occupational chemicals etc.) during pregnancy. | Pregnancies in which mothers had used Selective Serotonin Reuptake Inhibitor (SSRI) at any stage of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnancies unexposed to any antidepressant medications (exposure to agents not known to be teratogenic). |
843 / 1405 | 'Exposure to known or suspected human teratogens/fetotoxic agents were excluded'. Overlapping: this study included data published by Martin 2018 (abstract). |
| Robinson-Wolrath, 2016 |
Australia 2005 - 2010 |
All pregnancies at King Edward Memorial Hospital during the study period. | Mothers treated with Selective serotonin inhibitors (SSRIs) during pregnancy. |
unexposed (general population or NOS)
Mothers not treated with Selective serotonin inhibitors (SSRIs) nor Serotonin noradrenaline reuptake inhibitors (SNRIs) during pregnancy. |
295 / -9 | Number of unexposed pregnancies not specified (thus all data without OR provided by authors cannot be reported here). 75 babies of mothers prescribed multiple psychiatric medications excluded. |
| Roca, 2011 |
Spain 2004 - 2008 |
Pregnant women aged between 18 and 43 years old, visited a general teaching hospital, for the Perinatal Psychiatry Program. | Pregnant women with depressive or anxiety disorder who are treated with selective serotonin reuptake inhibitors (SSRIs) during regancy. |
unexposed, disease free
Pregnant women without an active psychiatric disorder during pregnancy who were non- exposed to antidepressants during pregnancy. |
84 / 168 | |
| Rommel, 2022 |
Denmark 1997 - 2015 |
Singletons (born 1997- 2015) whose mothers used antidepressants within one year before pregnancy. | Children whose mothers used selective serotonin reuptake inhibitors (SSRIs) monotherapy during pregnancy, i.e at least one prescription dispensed on any date from one month before pregnancy until delivery. |
unexposed, sick
Children whose mothers discontinued antidepressant before pregnancy (antidepressant use before but not during pregnancy). |
16429 / 23676 | Overlapping: large overlapping for PPHN (with Kieler 2012) and malformations (with Furu 2015) => outcomes not reported here because other studies included higher number of pregnancies and 1st trimester exposure for malformations. |
| Sahingöz (Controls unexposed, disease free), 2014 |
Turkey Not specified |
Women in perinatal period (from the 36th gestational week to 8 weeks postpartum) admitted to University and Hospitals in Konya and Istanbul, Turkey. | Consecutive women who were treated with selective serotonin reuptake inhibitors (SSRIs) for major depression during their current pregnancy. |
unexposed, disease free
Consecutive healthy women without any psychiatric disorder during their last pregnancy attending the outpatient clinic of neonatalogy for routine controls of their baby. |
23 / 30 | |
| Sahingöz (Controls unexposed, sick), 2014 |
Turkey Not specified |
Women in perinatal period (from the 36th gestational week to 8 weeks postpartum) admitted to University and Hospitals in Konya and Istanbul, Turkey. | Consecutive women who were treated with selective serotonin reuptake inhibitors (SSRIs) for major depression during their current pregnancy. |
unexposed, sick
Consecutive untreated women with major depression who attended outpatient clinics because of depressive symptoms during their current postnatal period. |
23 / 36 | |
| Salisbury (Controls unexposed, disease free), 2016 |
USA Not specified. |
Singleton pregnant women between 18 and 40 years old, 23–34 weeks gestation with a healthy singleton pregnancy (without illicit drugs, drugs for hypertension or diabetes, ...). | Infants of women who use Selective serotonin reuptake inhibitors (SSRI) for at least 4 weeks at any time during pregnancy among women with a current or lifetime diagnosis of a unipolar mood disorder. |
unexposed, disease free
Infants of women who did not meet criteria for any psychiatric disorder or report use of psychotropic medications during their entire pregnancy. |
52 / 66 | The SRI exposed group (n=52) is composed of SSRI (n=47) and SNRI (n=5; 9.6%). SNRI is less than 10% of the exposed group, thus it is considered as SSRI group. |
| Salisbury (Controls unexposed, sick), 2016 |
USA Not specified. |
Singleton pregnant women between 18 and 40 years old, 23–34 weeks gestation with a healthy singleton pregnancy (without illicit drugs, drugs for hypertension or diabetes, ...). | Infants of women who use Selective serotonin reuptake inhibitors (SSRI) for at least 4 weeks at any time during pregnancy among women with a current or lifetime diagnosis of a unipolar mood disorder. |
unexposed, sick
Infants of women pharmacologically untreated maternal depression. |
52 / 56 | The SRI exposed group (n=52) is composed of SSRI (n=47) and SNRI (n=5; 9.6%). SNRI is less than 10% of the exposed group, thus it is considered as SSRI group. |
| Scannell, 2020 |
USA 2007 - 2017 |
Pregnant women with depression and diabetes (type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM)) cared for at the Resident Diabetes in Pregnancy Clinic at a large, tertiary referral center. | Pregnant women with depression and diabetes who received medication therapy with Selective serotonin reuptake inhibitors (SSRIs). |
unexposed, sick
Pregnant women with depression and diabetes who did not receive medication therapy with Selective serotonin reuptake inhibitors (SSRIs). |
149 / -9 | The number of pregnancies in control group not clearly provided (maybe 69 (27 %) who had no treatment or 106 who had no SSRIs). |
| Simon (Controls exposed to TCA), 2002 |
USA 1986 - 1998 |
All live births of mothers continuously enrolled in Group Health Cooperative for 360 days before delivery. | Mothers with any selective serotonin reuptake inhibitor (SSRI) prescriptions during the 270 days before delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Mothers with any tricyclic antidepressants prescriptions during the 270 days before delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
185 / 209 | Mainly monoexposure of class: 'infants exposed to more than one antidepressant: 5 in the SSRI group (co-expo of SSRI), none in the tricyclic antidepressant group'. |
| Simon (Controls unexposed, NOS), 2002 |
USA 1986 - 1998 |
All live births of mothers continuously enrolled in Group Health Cooperative for 360 days before delivery. | Mothers with any selective serotonin reuptake inhibitor (SSRI) prescriptions during the 270 days before delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Mothers with no antidepressant prescriptions during the 360 days before delivery. |
185 / 185 | Mainly monoexposure of class: 'infants exposed to more than one antidepressant: 5 in the SSRI group (co-expo of SSRI), none in the tricyclic antidepressant group'. |
| Sivojelezova - Citalopram, 2005 |
Canada 1999 - 2002 |
Pregnant women or women planning pregnancy who contacted the Motherisk Program from inquiring about the safety of citalopram and other medications in pregnancy. | Women who took citalopram during pregnancy. |
unexposed (general population or NOS)
Pregnant women women with nonteratogenic exposures (eg, acetaminophen, hair dyes, vitamins, etc). |
132 / 132 | The disease-matched group treated with other SSRI antidepressants (eg, fluoxetine, paroxetine, sertraline) not reported here, because it also concerns exposure to SSRI. |
| Sjaarda, 2020 |
USA 2007 – 2011 |
Women 18–40 years of age, a history of one or two previous pregnancy losses, trying to conceive. | Women who became pregnant with exposure to selective serotonin reuptake inhibitors (SSRI) detected in urine samples during pregnancy. |
unexposed (general population or NOS)
Women who became pregnant without any antidepressant exposure at the same time point. |
75 / 662 | 'Women with SSRI use in this cohort may be considered to represent women with mild to moderate depression self-identified'. Results used were data for exposure at 'Week 4 of pregnancy' because available for all substances. |
| Skalkidou (Controls unexposed, disease free), 2020 |
Sweden 2013 - 2017 |
Pregnant women with singleton deliveries after gestational week 22 0 during the study period. | Pregnant women with self-reported selective serotonin reuptake inhibitor (SSRI) use at any time point during pregnancy. |
unexposed, disease free
Healthy pregnant women with no psychiatric illness or reporting selective serotonin reuptake inhibitor (SSRI) use. |
8643 / 268006 | Overlapping: for preterm: Skalkidou (2013 - 2017) included in Martin 2024 (2006-2020) => use of Martin 2024 because more exposed pregnancies and adjustments. |
| Skalkidou (Controls unexposed, sick), 2020 |
Sweden 2013 - 2017 |
Pregnant women with singleton deliveries after gestational week 22 0 during the study period. | Pregnant women with self-reported selective serotonin reuptake inhibitor (SSRI) use at any time point during pregnancy. |
unexposed, sick
Pregnant women with self-reported prior or current psychiatric illness but non-selective serotonin reuptake inhibitor (SSRI) treated during pregnancy. |
8643 / 28672 | Overlapping: for preterm: Skalkidou (2013 - 2017) included in Martin 2024 (2006-2020) => use of Martin 2024 because more exposed pregnancies and adjustments. |
| Skurtveit, 2014 |
Norway 1999 - 2008 |
Singleton pregnant women who attended the routine ultrasound appointment around week 17–18 of pregnancy at participating Norwegian hospitals. | Pregnant women that had reported use of any Selective serotonin reuptake inhibitors (SSRIs) at any time on the 17–18-week questionnaire (pregnancy week 0–18), or the 30-week questionnaire (week 19–29) or the 6-month questionnaire (week 30 until birth). |
unexposed (general population or NOS)
Pregnant women that had not reported use of any Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
386 / 51362 | Authors provided 2 durations of exposure (without results for any duration) => use of the maximal duration, i.e Use in at least two time periods. |
| Smith, 2013 |
USA 2004 - 2008 |
At term infant of women recruited from 137 clinicians' offices or hospital-based clinics in Connecticut and Western Massachusetts. | At term infant of mother who was not depressed in pregnancy yet was taking a serotonin reuptake inhibitor (only SSRI exposure) in the 3rd trimester. |
unexposed, disease free
At term infant of mother who was neither depressed nor taking antidepressant medications at any time in pregnancy. |
6 / 61 | Exposure to SRI included fluoxetine at a maximum of 20 mg/day, citalopram at an average dose of 20 mg/day, and sertraline at a maximum dose of 100 mg/day. |
| Stephansson, 2013 |
Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) 1996 - 2007 |
All singletons born after 154 gestational days during the study period. | One or more filled prescriptions for an Selective serotonin reuptake inhibitors (SSRIs) from 3 months before the start of pregnancy until birth (different analysis according to period of exposure). |
unexposed (general population or NOS)
No prescriptions for an Selective serotonin reuptake inhibitors (SSRIs). |
29228 / 1604649 | Exclusion of pregnancies who had used other antidepressants with a serotonin or norepinephrine activity (but not other antidepressants). Overlapping: Jimenez-Solem 2013 (Stephansson 2013 used for common outcomes). No overlapping with Lennestal 2007 |
| Suarez (Controls unexposed, discontinuers), 2022 |
USA 2000 - 2015 |
Individuals aged 12 to 55 years with live-birth deliveries linked to infants that have insurance coverage from 3 months before the date of the estimated last menstrual period (LMP) to 1 month after delivery. | Individuals with at least 1 dispensing of selective serotonin reuptake inhibitors (SSRIs) from 127 days after LMP (week 19 of gestation) to delivery. |
unexposed, sick
Individuals that having a dispensing for selective serotonin reuptake inhibitors (SSRIs) in the window from 90 to 31 days prior to LMP but not during the window of 30 days prior to LMP through delivery. |
115060 / 38038 | The Medicaid Analytic eXtract (MAX): 2000 to 2014 and the MarketScan Commercial Claims Database (MarketScan): 2003 to 2015. |
| Suarez (Controls unexposed, general pop), 2022 |
USA 2000 - 2015 |
Individuals aged 12 to 55 years with live-birth deliveries linked to infants that have insurance coverage from 3 months before the date of the estimated last menstrual period (LMP) to 1 month after delivery. | Individuals with at least 1 dispensing of selective serotonin reuptake inhibitors (SSRIs) from 127 days after LMP (week 19 of gestation) to delivery. |
unexposed (general population or NOS)
Individuals with no antidepressant dispensing from 90 days prior to pregnancy start through the day prior to delivery. |
115110 / 3000907 | The Medicaid Analytic eXtract (MAX): 2000 to 2014 and the MarketScan Commercial Claims Database (MarketScan): 2003 to 2015. |
| Sujan (Controls unexposed, NOS), 2017 |
Sweden 1996 - 2012 |
About all offspring born in Sweden during the study period and followed up through 2013. | Singleton offspring whose mother had first-trimester exposure to any selective serotonin reuptake inhibitors (SSRIs). (This is a subgroup of exposure among the whole exposed group considered). |
unexposed (general population or NOS)
Unexposed singleton offspring. |
18470 / 1562159 | Use of data based on Maternal self-reported questionnaire. For preterm and SGA: overlapping between Reis 2010 (1995-2007); Norby (2006-2012) and Sujan 2017 (1996-2012): use of Reis and Norby because more exposures and more relevant period of exposure. |
| Sujan (Controls unexposed, sibling), 2017 |
Sweden 1996 - 2012 |
About all offspring born in Sweden during the study period and followed up through 2013. | Singleton offspring whose mother had first-trimester exposure to any selective serotonin reuptake inhibitors (SSRIs). (This is a subgroup of exposure among the whole exposed group considered). |
sibling
Siblings born to the same mothers discordant in view of exposure: no exposure to selective serotonin reuptake inhibitors (SSRIs). |
9063 / 15906 | Preterm, SGA: Overlapping: Norby and Reis used rather than Sujan 2017 (less exposures). First-trimester exposure: at least 1 dispensation between 90 days before and 90 days after conception: Sensitivity analysis restricted to 30 days => considered as T1. |
| Suri, 2007 |
USA 2000 - 2005 |
Pregnant women from the Women’s Life Center clinic, between the ages of 18 and 45, and who were in the first trimester of pregnancy. | Pregnant women with major depressive disorder who took antidepressant medication (> 90% selective serotonin reuptake inhibitors (SSRIs)) for more than 50% of their pregnancy |
unexposed, disease free
Healthy pregnant women with no psychiatric history. |
49 / 19 | In the group exposed to antidepressants, more than 90% were exposed to selective serotonin reuptake inhibitors (SSRIs), there this group is considered as exposed to SSRIs. |
| Suri - Fluoxetine (Controls unexposed, disease free), 2004 |
USA 1997 - 2000 |
Singleton Pregnant women between the ages of 18 and 45 in the first trimester of pregnancy with either a history of major depressive disorder or no psychiatric history recruited from outpatient obstetrician-gynecologist practices or from the UCLA outpatient Women’s Life Center psychiatric clinic. | Pregnant women with depression treated with fluoxetine at any time during pregnancy (medicated depressed group). |
unexposed, disease free
Pregnant women without depression and no antidepressant treatment during pregnancy. |
28 / 16 | 'Exclusion criteria included the presence of psychotic symptoms, the use of medications that are known to adversely affect the fetus, the use of other psychotropic medications, the use of alcohol, cigarettes, or substances while pregnant'. |
| Suri - Fluoxetine (Controls unexposed, sick), 2004 |
USA 1997 - 2000 |
Singleton Pregnant women between the ages of 18 and 45 in the first trimester of pregnancy with either a history of major depressive disorder or no psychiatric history recruited from outpatient obstetrician-gynecologist practices or from the UCLA outpatient Women’s Life Center psychiatric clinic. | Pregnant women with depression treated with fluoxetine at any time during pregnancy (medicated depressed group). |
unexposed, sick
Pregnant women with depression and no antidepressant treatment during pregnancy (unmedicated depressed group). |
28 / 18 | 'Exclusion criteria included the presence of psychotic symptoms, the use of medications that are known to adversely affect the fetus, the use of other psychotropic medications, the use of alcohol, cigarettes, or substances while pregnant'. |
| Sørensen (Controls exposed to TCA), 2013 |
Denmark 1996 - 2006 |
All children born alive in Denmark during the study period. | Children of women who filled a prescription for Selective serotonin reuptake inhibitor (SSRI) from 30 days before conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children of women who filled a prescription for Tricyclic antidepressants (TCA) from 30 days before conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
7506 / 642 | For ASD: overlapping between Gidaya 2014, Hviid 2013; Sorensen 2013 and Liu 2017 (same dataset and period) => Liu was reported because larger study with an unexposed sick comparator. Low co-exposure SSRI/SNRI/TCA (<5%) => considered as monotherapies. |
| Sørensen (Controls unexposed, NOS), 2013 |
Denmark 1996 - 2006 |
All children born alive in Denmark during the study period. | Children of women who filled a prescription for Selective serotonin reuptake inhibitor (SSRI) from 30 days before conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children of women who not filled antidepressant drugs during pregnancy. |
7506 / 646782 | For ASD: overlapping between Gidaya 2014, Hviid 2013; Sorensen 2013 and Liu 2017 (same dataset and period) => Liu was reported because larger study with an unexposed sick comparator. Low co-exposure SSRI/SNRI/TCA (<5%) => considered as monotherapies. |
| Sørensen (Controls unexposed, sibling), 2013 |
Denmark 1996 - 2006 |
All children born alive in Denmark during the study period of a mother with at least one child with autism spectrum disorder. | Siblings children born to mothers who filled selective serotonin reuptake inhibitor (SSRI) from 30 days before conception to the day of birth. |
sibling
Siblings children born to mothers who not filled selective serotonin reuptake inhibitor (SSRI) drugs during pregnancy. |
81 / 6036 | For ASD: overlapping between Gidaya 2014, Hviid 2013; Sorensen 2013 and Liu 2017 (same dataset and period) => Liu was reported because larger study with an unexposed sick comparator. Low co-exposure SSRI/SNRI/TCA (<5%) => considered as monotherapies. |
| Sørensen (Controls unexposed, sick), 2013 |
Denmark 1996 - 2006 |
All children born alive in Denmark during the study period of mothers with a hospital-diagnosed affective disorder. | Children born to mothers with a hospital-diagnosed affective disorder who filled a prescription for selective serotonin reuptake inhibitor (SSRI) from 30 days before conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to mothers with a hospital-diagnosed affective disorder who not filled antidepressant drugs during pregnancy. |
1475 / 4324 | For ASD: overlapping between Gidaya 2014, Hviid 2013; Sorensen 2013 and Liu 2017 (same dataset and period) => Liu was reported because larger study with an unexposed sick comparator. Low co-exposure SSRI/SNRI/TCA (<5%) => considered as monotherapies. |
| Talati (Controls unexposed, general pop), 2025 |
|
unexposed (general population or NOS)
|
820 / 863 | Only the result is extracted for potential retrieval at a later stage, as the outcome is not currently considered in metaPreg. | ||
| Talati (Controls unexposed, sick), 2025 |
|
unexposed, sick
|
820 / 399 | Only the result is extracted for potential retrieval at a later stage, as the outcome is not currently considered in metaPreg. | ||
| Ter Host (Controls exposed to TCA), 2013 |
The Netherlands 1995 - 2009 |
Children selected by date of birth (between 1995 - 2009) and the female person (15–50 years) with the same address code (considered to be the mother). | Children of mothers exposed to Serotonin reuptake inhibitors (SSRIs) during pregnancy. |
exposed to other treatment, sick
Children of mothers exposed to Tricyclic antidepressants (TCAs) during pregnancy. |
436 / 67 | The group exposed to both a SSRI and a TCA was excluded from the TCA exposed group and SSRI exposed group. Paroxetine (266), fluoxetine (111), citalopram (91), fluvoxamine (70), sertraline (34), and escitalopram (11). |
| Ter Host (Controls unexposed, NOS), 2013 |
The Netherlands 1995 - 2009 |
Children selected by date of birth (between 1995 - 2009) and the female person (15–50 years) with the same address code (considered to be the mother). | Children of mothers exposed to Serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed (general population or NOS)
Children of mothers who did not use any selective serotonin re-uptake inhibitors (SSRIs) or tricyclic antidepressants (TCAs) during pregnancy and during a period of 7 days before pregnancy. |
436 / 35033 | The group exposed to both a SSRI and a TCA was excluded from the TCA exposed group and SSRI exposed group. Paroxetine (266), fluoxetine (111), citalopram (91), fluvoxamine (70), sertraline (34), and escitalopram (11). |
| Toh a, 2009 |
USA and Canada 1998 - 2007 |
Pregnant women who gave birth to nonmalformed live-born babies during the study period. | Pregnant women that receive selective serotonin reuptake inhibitor (SSRI) treatment during pregnancy. |
unexposed (general population or NOS)
Pregnant women who did not receive selective serotonin reuptake inhibitor (SSRI) treatment during pregnancy. |
92 / 5532 | Consideration of 'Continued SSRI exposure subjects' that were women treated with SSRIs 2 months before pregnancy who continued treatment after the first trimester. |
| Toh b, 2009 |
USA and Canada 1998 - 2008 |
Pregnant women who gave birth to nonmalformed live-born infants during the study period. | Pregnant women who used selective serotonin reuptake inhibitor (SSRI) only during pregnancy. |
unexposed (general population or NOS)
Pregnant women with no antidepressant use from 2 months before pregnancy through delivery. |
192 / 5710 | Consideration of women that remained on treatment beyond the first trimester (SSRI continuers). 'Women who used both SSRIs and non-SSRI antidepressants were excluded.'. |
| Tran (Controls exposed to TCA), 2022 |
The Netherlands 2000 - 2010 |
Pregnant women who had her first pregnancy (primigravida) with a singleton during the study period. | Pregnant women who received a dispensing of Selective serotonin reuptake inhibitors (SSRIs) between weeks 0–20 of gestation or received before pregnancy, but the treatment duration lasted into pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women who received a dispensing of tricyclic antidepressants (TCAs) between weeks 0–20 of gestation or received before pregnancy, but the treatment duration lasted into pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
1488 / 214 | The RR provided by authors (for TCAs versus SSRI) not reported here because Fluoxetine excluded of SSRI class and no adjustment. |
| Tran (Controls unexposed, NOS), 2022 |
The Netherlands 2000 - 2010 |
Pregnant women who had her first pregnancy (primigravida) with a singleton during the study period. | Pregnant women who received a dispensing of Selective serotonin reuptake inhibitors (SSRIs) between weeks 0–20 of gestation or received before pregnancy, but the treatment duration lasted into pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who did not receive antidepressants in 15 months before delivery. |
1488 / 95376 | |
| Ulbrich, 2021 |
USA 2017 - 2018 |
Full-term singleton newborn born at the studied hospital during a 6-month time period. | Third trimester maternal Selective serotonin reuptake inhibitor (SSRI) exposure. |
unexposed (general population or NOS)
No Selective serotonin reuptake inhibitor (SSRI) exposure. |
163 / 4770 | SSRI: fluoxetine (n = 20), sertraline (n = 96), citalopram (n = 14), escitalopram (n = 30), fluvoxamine (n = 1), and paroxetine (n = 2). |
| Van der Veere, 2020 |
The Netherlands 2007 - 2010 |
Pregnant women, living in the vicinity of two Level-2 hospitals in the Northern part of the Netherlands were recruited via newspapers, midwifes, general practitioners, gynecologists, and psychiatrists. | Children who had been exposed to a selective serotonin reuptake inhibitors (SSRI) during pregnancy. |
unexposed (general population or NOS)
Children who had not been exposed to psychotropic medication during pregnancy, with adjustment for maternal psychopathology. |
61 / 41 | Preterm, birth weight < P10, Apgar score ≤ 5 at 5 min not reported due to Overlapping with DeVries 2013. 'Venlafaxine was considered to work as an SSRI if given in low doses. Women taking < 200 mg venlafaxine were included in the SSRI group' |
| Vasilakis-Scaramozza (Controls exposed to TCA), 2013 |
United Kingdom 1991 - 2002 |
Offspring of singleton pregnancies among women aged 15–45 years that occurred during the study period. | Pregnant women with a diagnosis of depression and with at least one prescription for selective serotonin reuptake inhibitor (SSRI) during the first trimester of pregnancy or within 4 weeks of the estimated first day of the last menstrual period. |
exposed to other treatment, sick
Pregnant women with a diagnosis of depression and with at least one prescription for Tricyclic antidepressants during the first trimester of pregnancy or within 4 weeks of the estimated first day of the last menstrual period. |
1825 / 1608 | 'Antidepressant exposure categories (tricyclics or SSRI) are not mutually exclusive.' but only 157 women were exposed to both tricyclics and SSRI (< 10%) => comparison between tricyclics and SSRI can be made. |
| Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 |
United Kingdom 1991 - 2002 |
Offspring of singleton pregnancies among women aged 15–45 years that occurred during the study period. | Pregnant women with a diagnosis of depression and with at least one prescription for selective serotonin reuptake inhibitor (SSRI) during the first trimester of pregnancy or within 4 weeks of the estimated first day of the last menstrual period. |
unexposed (general population or NOS)
Pregnant women not exposed to any antidepressant during the first trimester of pregnancy. |
1825 / 6617 | Overlapping of 'Congenital heart defects' with a larger study published by Margulis 2013, thus this outcome was not reported here. 'Women with exposure to other antidepressants in the first trimester of pregnancy were excluded from the analysis.' |
| Vial - Paroxetine, 2006 |
France 1994 - 2005 |
Not specified. | Pregnant women exposed to paroxetine during early pregnancy (i.e. 3 to 10 weeks after the last menstrual period). |
unexposed (general population or NOS)
Pregnant women who were unexposed or exposed to a non-teratogenic agent during organogenesis. |
683 / -9 | |
| Viktorin, 2017 |
Sweden 2005 - 2007 |
All live-born children during the study period. | Offspring born to mothers with at least 2 dispensations of selective serotonin reuptake inhibitor (SSRI) with medication periods that overlapped the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Offspring born to mothers without these medications use during pregnancy. |
3178 / 172646 | |
| Viktorin b, 2017 |
Sweden 2006 - 2014 |
All live-born children conceived from July 1, 2005 and born in 2006 and 2007. | Offspring that were born to mothers with at least 2 dispensations of selective serotonin reuptake inhibitors (SSRIs) overlapping the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Offspring that were born to mothers without any dispensation of an antidepressant with a medication period overlapping the pregnancy. |
3178 / 172646 | Overlapping: Autism spectrum disorder not reported here because the same dataset was used for a larger study published by Sujan 2017. |
| Wall-Wieler, 2020 |
USA 2008 - 2015 |
Pregnant women with have a prepregnancy depression diagnosis, among women aged 15 to 44. | Pregnant women having a Selective serotonin reuptake inhibitor (SSRI) prescription that had at least a 1-day supply in the 3 weeks after a woman’s estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women who had a prepregnancy depression diagnosis and did not have Selective serotonin reuptake inhibitor (SSRI) prescription, but that could they could be exposed to an antidepressant (but not that class). |
28434 / 78354 | Non exposed group: a majority is non exposed to antidepressant (n=66501) whereas the other one are exposed to an other class of antidepressants. |
| Wen, 2006 |
Canada 1990 - 2000 |
All live births and stillbirths in Saskatchewan to Saskatchewan residents during the study period. | Pregnant women with at least 1 Selective serotonin reuptake inhibitor (SSRI) prescription that was dispensed in the 1-year period before delivery. |
unexposed (general population or NOS)
Pregnant women non exposed to Selective serotonin reuptake inhibitors (SSRIs) selected from the remainder of the database. |
972 / 3878 | Most of the patients used only 1 category of SSRI. No information related to other antidepressants. |
| Wichman, 2009 |
USA 1993 - 2005 |
All pregnant women presenting at Mayo Clinic’s site in Rochester during the study period. | Mothers were treated with Selective serotonin reuptake inhibitors (SSRIs) at some point during their pregnancy. |
unexposed (general population or NOS)
All other women, i.e not exposed to Selective serotonin reuptake inhibitors (SSRIs). |
808 / 24406 | Amon SSRI exposed women, 53 (6.6%) were exposed to a SRI (venlafaxine) |
| Wisner (Controls unexposed, disease free), 2009 |
USA 2000 - 2007 |
Pregnant women between 15–44 years of age recruited through physician referral, advertising, and screening in obstetric practices. | Pregnant women with major depressive disorder, treated with Selective serotonin reuptake inhibitor (SSRI) during the entirety of pregnancy or for the majority of each of the three trimesters. |
unexposed, disease free
Pregnant women with no exposure to any antidepressant or to major depressive disorder. |
48 / 131 | Overlapping: Wisner 2013 totally included in Wisner 2009. |
| Wisner (Controls unexposed, sick), 2009 |
USA 2000 - 2007 |
Pregnant women between 15–44 years of age recruited through physician referral, advertising, and screening in obstetric practices. | Pregnant women with major depressive disorder, treated with Selective serotonin reuptake inhibitor (SSRI) during the entirety of pregnancy or for the majority of each of the three trimesters. |
unexposed, sick
Pregnant women with major depression throughout pregnancy or for the majority of each of the three trimesters, without Selective serotonin reuptake inhibitor (SSRI) treatment. |
48 / 14 | Overlapping: Wisner 2013 totally included in Wisner 2009. |
| Wu, 2019 |
USA 2000 - 2012 |
Enrolled women who were either planning to conceive or were pregnant (before 12 wks of completed gestation). | Pregnant women reported any use of selective serotonin reuptake inhibitors (SSRIs) during their first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who never used antidepressants during the first trimester of pregnancy. |
179 / 5228 | 'Women with induced abortions and ectopic pregnancies were also excluded.' Exposure to SSRI considered as 'SSRI only' (because 95% (170/179) of SSRI only users). |
| Yang, 2021 |
Taiwan 2010 - 2016 |
First recorded singleton pregnancies in women aged 18 to 49 years who gave birth during the study period with at least 1 outpatient or 1 inpatient diagnosis of depression between 12 months before the start of pregnancy and the start of the 20 weeks’ gestation. | Pregnant women with depression and at least 1 prescription for an oral selective serotonin reuptake inhibitors (SSRI) from the day of pregnancy initiation up to the start of 20 weeks of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with depression without antidepressant prescription. |
1547 / 2832 | 'In addition, we restricted the cohort of antidepressant users to patients who were only prescribed 1 consistent anti- depressant during the exposure period.' |
| Yang (Controls unexposed, disease free), 2017 |
USA 2000 - 2011 |
Pregnant women between 18–44 years of age recruited through physician referral, advertising, and screening in obstetric practices. | Pregnant women with a mood disorder (either major depressive or bipolar disorder) and who were taking an SRI but had no exposure to any antimanic drugs or benzodiazepines during pregnancy (the final 4 weeks of pregnancy). |
unexposed, disease free
Pregnant women who did not take psychotropics at any point during pregnancy and who did not have a major mood disorder. |
41 / 79 | The 41 SRI-exposed women were treated with SSRI (n=38) or venlafaxine (n = 3) => SSRI more than 90% => considered as SSRI group. Overlap with Wisner 2009 which include more pregnancies for preterm, neonatal intensive care, and Apgar (not reported here). |
| Yang (Controls unexposed, sick), 2017 |
USA 2000 - 2011 |
Pregnant women between 18–44 years of age recruited through physician referral, advertising, and screening in obstetric practices. | Pregnant women with a mood disorder (either major depressive or bipolar disorder) and who were taking an SRI but had no exposure to any antimanic drugs or benzodiazepines during pregnancy (the final 4 weeks of pregnancy). |
unexposed, sick
Pregnant women with either mood disorder or bipolar disorder but who did not take psychotropic medications at any point during pregnancy. |
41 / 94 | The 41 SRI-exposed women were treated with SSRI (n=38) or venlafaxine (n = 3) => SSRI more than 90% => considered as SSRI group. Overlap with Wisner 2009 which include more pregnancies for preterm, neonatal intensive care, and Apgar (not reported here). |
| Yaris, 2005 |
Turkey 1999 - 2004 |
Pregnant women calling for a counseling about the teratogenic risks of drugs, chemicals, and X-ray. | Women who were exposed to Selective Serotonin Re-uptake Inhibitor (SSRIs) during pregnancy for depression, anxiety, and psychotic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Women who did not use any drug while pregnant. |
54 / 248 | Addition of exposures to Fluoxetine (17), Sertraline (16), Fluvoxamine (9), Citalopram (7), Paroxetine (4) and escitalopram (1). Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. |
| Yeh, 2021 |
Taiwan 2002 - 2011 |
Pregnant women with bipolar disorder who were pregnant and gave birth to a child during the study period. | Pregnant women with bipolar disorder receiving selective serotonin reuptake inhibitors (SSRI - fluoxetine, sertraline, citalopram, escitalopram, paroxetine, fluvoxamine) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with bipolar disorder not receiving any psychotropics before and during the pregnancy. |
163 / 5243 | For ADHD any trimester: inconsistency in OR and 95%CI provided by authors => Probable mistake: 2.30 [2.47; 3.62]: lower CI born < estimate => replace by 1.47 (instead of 2.47). |
| Zakiyah, 2018 |
The Netherlands 1994 - 2015 |
Singleton pregnant women who were registered in the IADB.nl pregnancy database during the study period. | At least one dispensing record of selective serotonin reuptake inhibitors (SSRIs) between the theoretical conception date and 20 completed weeks of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women that were without antidepressant prescriptions in the period of 6 months prior to the theoretical conception date until 20 completed weeks of gestation. |
394 / 27481 | Among the 539 exposure antidepressants as a whole, about 3% have co-exposure of different class of antidepressants => Considered as monotherapy of TCAs, SSRIs, .... |
| Zeskind, 2004 |
USA Not specified |
Postpartum mothers who were 19 to 45 years of age and their 1- to 2-day-old newborns who were recruited at Carolinas Medical Center in Charlotte, North Carolina. | Newborn infants whose mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
unexposed (general population or NOS)
Newborn infants whose mothers who did not use selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
17 / 17 | All mothers continued taking SSRIs up to labor and delivery, except for 1 mother who reported that she stopped taking Zoloft late in the third trimester. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|---|---|---|---|---|
| Alwan, 2007 |
USA 1997 - 2002 |
The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. | The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. | 9622 / 4092 | Overlapping: Major Malformations and individual malformations not reported because updated by Anderson 2020. 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.' |
| Ames (Controls unexposed, disease free), 2021 |
USA 2003 - 2011 |
Children with Autism spectrum disorder (ASD) or with other developmental delays or disorders (DDs) such as language delay or intellectual disability (ID) recruited from educational and clinical settings that serve children with developmental disorders. | Children from the general population randomly sampled state birth records at each study site who either scored <11 on the SCQ or scored >=11 but did not meet ASD criteria after the in-person assessment. | 1750 / 1671 | The final analytic sample comprised 1367 children with ASD, 1750 with DDs, and 1671 POP controls. No age specified in article but in CDC website: 'The study will include children with ASD, with other DDs, and with typical development, ages 2-5 years'. |
| Ames (Controls unexposed, sick), 2021 |
USA 2003 - 2011 |
Children with Autism spectrum disorder (ASD) or with other developmental delays or disorders (DDs) such as language delay or intellectual disability (ID) recruited from educational and clinical settings that serve children with developmental disorders. | Children from the general population randomly sampled state birth records at each study site who either scored <11 on the SCQ or scored >=11 but did not meet ASD criteria after the in-person assessment. | 329 / 328 | The final analytic sample comprised 1367 children with ASD, 1750 with DDs, and 1671 POP controls. No age specified in article but in CDC website: 'The study will include children with ASD, with other DDs, and with typical development, ages 2-5 years'. |
| Anderson, 2020 |
USA 1997 - 2011 |
The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. | The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. | 30630 / 11478 | Overlapping: this study is an update of Alwan 2007, Nembhard 2017, Werler 2018 (gastroschisis) and Lind 2013 (hypospadias). 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.' |
| Bakker - Paroxetine, 2010 |
The Netherlands 1997 - 2006 |
Fetuses or children born with isolated congenital heart defects (included fetuses or children with simple or complex heart defects only and excluded fetuses or children with associated genetic or other syndromes or those with extracardiac malformations.) | Fetuses and children with a chromosomal or single gene disorder as controls (with exclusion of children with an associated heart defect ) | 678 / 615 | Overlapping with Wemakor 2015, a larger study based on 12 EUROCAT registries (included The Netherlands) for VSD, ASD, septal defects and cardiac malformations. Results not reported here. |
| Boyle, 2017 |
12 European countries (DK, FR, NL, SW, MT, BE, DE, UA, IR, IT, UK, SP) 1982 - 2011 |
Cases of Ebstein’s anomaly (live births, fetal deaths from 20 weeks gestation, and terminations of pregnancy). | Cases of Non-cardiac anomaly (live births, fetal deaths from 20 weeks gestation, and terminations of pregnancy). | 173 / 51024 | Exclusion of teratogenic syndrome in both cases and controls. Exclusion of cases and controls exposed to diabetes. |
| Chambers, 2006 |
USA and Canada 1998 - 2003 |
Mothers of subjects with Persistent pulmonary hypertension of the newborn (PPHN). | Mothers of subjects without Persistent pulmonary hypertension of the newborn (PPHN). | 377 / 836 | |
| Clements, 2015 |
USA 1997 - 2010 |
Infants who had at least one ICD-9 code of 299 (pervasive developmental disorder) or with ICD-9 code of 314.x (attention-deficit hyperactivity disorder (ADHD)). | Infants not having any prior history of Autism Spectrum Disorder (ASD), attention-deficit hyperactivity disorder (ADHD) or intellectual disability (ICD9 of 299, 314 or 317–319). | 2243 / 5631 | 1377 children with ASD matched to 4022 healthy control children and 2243 with ADHD (but no ASD diagnosis) matched to 5631 healthy control children. |
| Croen, 2011 |
USA 1995 - 1999 |
Children with at least 1 diagnosis of autism (ICD-9-CM code 299.0), Asperger syndrome (ICD-9-CM code 299.8), or pervasive developmental disorder not otherwise specified (ICD-9-CM code 299.8). | Children without an Autism spectrum disorder diagnosis randomly sampled from the remaining cohort of live births. | 298 / 1507 | Analysis restricted to the subgroup of women with a history of a mental health not reported from this study because the only one considered exposure is 3 months before pregnancy or during pregnancy. |
| Dandjinou, 2019 |
Canada 1998 - 2015 |
Pregnant women with a diagnosis of gestational diabetes mellitus (GDM) identified using diagnosis codes ICD-9: 250.0–250.9, 648.0, 648.8, 790.2, 775.1 or ICD-10: E10–E14, O24, R73.0) or at least one filled prescription for an antidiabetic drug allowed during pregnancy (insulin, glyburide or metformin), both after week 20 of gestation, whichever occurred first. | Pregnant women that did not have a diagnosis of gestational diabetes mellitus (GDM) at the index date. | 20905 / 209050 | The 10 categories of exposure were mutually exclusive. |
| Dave, 2019 |
USA 2011 - 2015 |
Neonatal abstinence syndrome (NAS) in live births. | No neonatal abstinence syndrome (NAS) in live births. | 659 / 621281 | |
| De Jonge - Paroxetine only, 2013 |
The Netherlands 1998 - 2008 |
All malformed foetuses and children (live births, stillbirths, spontaneous abortions and terminations of pregnancy) excluding chromosomal and genetic disorders. | From the IADB, a population-based prescription database that contains prescription data from approximately 55 community pharmacies in The Netherlands, we selected the population controls. The IADB covers an estimated population of 500,000 individuals, which is considered representative of the general population. | 3212 / 29223 | Overlapping with Wemakor 2015, a larger study based on 12 EUROCAT registries (including The Netherlands) for cardiac, respiratory and digestive malformations => not reported here. Several SSRIs studied => To avoid redundancy of control, use of paroxetine. |
| De Vera, 2012 |
Canada 1997 - 2003 |
Women with a diagnosis of gestational hypertension (ICD-9: 642.3, 642.0), pre-eclampsia (ICD-9: 642.4, 642.5) or eclampsia (ICD-9: 642.6) after the 20th week of gestation. | Women who did not have a diagnosis of pregnancy-induced hypertension at or before the same gestational age. | 1216 / 12160 | |
| Eriksson, 2012 |
Sweden 2002 – 2006 |
Children with a clinical diagnosis of Autism spectrum disorders (ASD). | All children born alive in Stockholm County, excluding children with a clinical diagnosis of ASD in the county. | 188 / 173390 | |
| Given, 2017 |
14: Belgium, Croatia, Denmark, FR, Germany, Ireland, Italy, Netherlands, Norway, Ukraine, UK... 1995 - 2012 |
Infants with gastroschisis (ICD-9 with BPA extension code 75671 or ICD-10 code Q793). | Infants with a diagnosis of a major congenital anomaly not including gastroschisis. | 1587 / 154877 | Overlapping; this study updated Wemakor 2015 for gastroschisis. Medications taken in the second or third trimester or where the timing was unknown were excluded. |
| Granstrom, 2019 |
Sweden 2006 - 2012 |
All cases with an ICD code for Hirschsprung disease (HSCR) (ICD-8, 751.39; ICD-9, 751D; ICD-10: Q431). | Neonates without a history of Hirschsprung disease (HSCR). | 150 / 750 | |
| Harrington, 2014 |
USA 2003 - 2010 |
Children with autism spectrum disorders (ASDs), with developmental delays (DDs) other than ASD. | Children with typical development. | 646 / 320 | |
| Hartwig, 2022 |
The Netherlands 1995 - 2016 |
Children receiving at least two consecutive prescriptions for Attention-deficit/hyperactivity disorder (ADHD) medication (i.e., methylphenidate, dextroamphetamine, or atomoxetine) before the age of 16, with 'consecutive' meaning the second prescription being received within 6 months. | Sibling of a case, being born from the same womb, with no prescriptions for MPH, dextroamphetamine, or atomoxetine during follow-up until the 16th birthday. | 1304 / 1529 | |
| Kawai, 2023 |
Japan 2011 - 2014 |
Child having a Congenital Heart Defect (CHD), i.e physicians reported at birth, 1 month, 6 months, age 1 year, or 2 years that the child had CHD in the questionnaires. | Child that did not have a Congenital Heart Defect (CHD). | 1264 / 90400 | |
| Kerr, 2018 |
USA and Canada 1993 - 2015 |
Infants with microcephaly alone (“isolated”) and microcephaly that included other major birth defects (“non-isolated”), | Nonmalformed live-born infants. | 166 / 12059 | Authors analyzed separately “isolated” microcephaly and “non-isolated” microcephaly. Only isolated microcephaly are indexed in MetaPreg. |
| Kieler, 2015 |
Denmark, Finland, and Norway 1996 - 2007 |
Women with elective termination of pregnancy at 12–23 weeks of gestation. | Women that continued their pregnancy, randomly selected and matched with cases on key factors. | 14902 / 148929 | SSRIs (fluoxetine, citalopram, paroxetine, sertraline, fluvoxamine, and escitalopram). The (ORs) are presented for women exposed to only one type of antidepressant during the exposure period. |
| Kitchin, 2022 |
Spain 2002 - 2015 |
Pregnant woman suffering a miscarriage. | Pregnant woman randomly selected from the whole cohort among women who were still at risk within follow-up, by risk-set sampling and individually matched to cases. | 18070 / 54209 | |
| Laspro - Sertraline, 2024 |
USA 2013 - 2023 |
Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37). | Newborns without oral clefts. | 12098 / -9 | Laspro et al provided results for several SSRIs => to avoid redundancy of controls, only one can be used => this one with more exposed pregnancies (i.e Sertraline). |
| Louik, 2007 |
USA and Canada 1993 - 2004 |
Infants with any of a wide range of malformations with exclusion of isolated minor defects (e.g., accessory nipples, dislocatable hips, and low-set ears). | Nonmalformed infants. | 9849 / 5860 | Exclusion of subjects whose infants had chromosomal defects, known mendelian inherited disorders, syndromes, defects with a known cause (e.g., fetal alcohol syndrome), and metabolic disorders. Overlapping: Conotruncal defects (Louik 2014). |
| Louik, 2014 |
USA and Canada 1992 - 2011 |
Infants with any of a wide range of malformations (infants with isolated minor defects are excluded).. | Infants without malformations. | 2734 / 8611 | |
| Man, 2015 |
Hong Kong 2001 - 2014 |
Children diagnosed with autism spectrum disorder (ASD). | Children without diagnosis of autism spectrum disorder (ASD). | 4208 / 292758 | 299 672 children included in the analysis. 4208 and 2706 children were diagnosed with ASD and ADHD, respectively. Results of ADHD not reported here, because a more detailed article was published by the same authors (Man 2017) related specifically to ADHD. |
| Nakhai-Pour, 2010 |
Canada 1998 - 2003 |
Pregnant women with a diagnosis or a procedure for spontaneous abortion between the first day and the 20th week of gestation. | Randomly selected pregnant women who did not have a spontaneous abortion at or before the same gestational age as their matched case did. | 5124 / 51240 | |
| Neo, 2020 |
USA 2010 - 2016 |
Infants treated with therapeutic hypothermia for concern for hypoxic ischemic encephalopathy (HIE). | Controls were the next four noncase deliveries within 6 months of the case. | 38 / 148 | |
| Ogawa, 2018 |
Japan 2005 - 2014 |
Mothers who had experienced preterm birth or had given birth to a low birth weight infant. | Mothers who had neither experienced preterm birth nor had given birth to a low birth weight infant, as recorded in the claims data. | 1615 / 40224 | Selective serotonin reuptake inhibitors: escitalopram, fluvoxamine, paroxetine, and sertraline. |
| Salkeld, 2008 |
Canada 1999 - 2005 |
Pregnant women with a delivery complicated by postpartum hemorrhage. | Pregnant women with a delivery uncomplicated by postpartum hemorrhage. | 2460 / 23943 | |
| Solé, 2020 |
Spain 2005 - 2017 |
Pregnant women who had a C-Section (C-Section group). | Pregnant women who had a vaginal delivery (non-C-Section group). | 40 / 60 | |
| Wemakor, 2015 |
Belgium, Spain, Ireland, Malta, Netherlands, Norway, Denmark, FR, Germany, Italy, Switzerland, UK 1995 - 2009 |
Babies with congenital heart defects (CHD) or with congenital anomalies other than CHD identified as significantly associated with SSRI exposure (‘‘signals’’) in at least one previous study. | All other registrations. | 12876 / 17083 | Overlapping: for gastroschisis and Ebstein's anomay, Given 2017 and Boyle 2017 published an updated and larger study based on EUROCAT data (thus these outcomes not reported here). |
| Wilson, 2011 |
USA 2003 - 2009 |
Neonates born at >34 weeks gestation and verified to have primary Persistent pulmonary hypertension of the newborn (PPHN). | The next six births of cases occurring at the same gestational age in weeks were identified from the hospital’s delivery log. | 20 / 120 | Neonates with congenital anomalies known to cause pulmonary hypertension (e.g., diaphragmatic hernia) were excluded. Cases of meconium aspiration syndrome and neonatal pneumonia and sepsis were also excluded. |
| Yazdy, 2014 |
USA 2006 - 2011 |
Infants with a diagnosis of talipes equinovarus ('clubfoot') without a known syndrome. | Infants with no major malformations or foot problems, drawn from the same birth population as cases and selected from either birth certificates (Massachusetts and north carolina) or hospital medical records (new York). | 622 / 2002 | No overlapping between Yazdy 2014 (2006 - 2011) and Louik 2007 (1993 - 2004). |
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