| Study | Type of data | Exposure measurement | Outcome assessment | Adjustment |
|---|---|---|---|---|
| Alwan, 2007 | case control | Information on exposure to SSRIs and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants conducted in English or Spanish. | Case infants were ascertained through population-based birth-defects surveillance systems in eight U.S. states. Controls were selected randomly from the same geographic areas. Information on the case infants was reviewed by clinical geneticists unaware of the infants’ exposure status | Odds ratios are adjusted for maternal race or ethnic group, presence or absence of maternal obesity, presence or absence of maternal smoking, and family income. Infants whose mothers had prepregnancy type 1 or 2 diabetes mellitus are excluded. |
| Ames (Controls unexposed, disease free), 2021 | case control | Maternal use of SSRIs during pregnancy were ascertained from all participants in three ways: self-report in a telephone interview shortly after study enrollment (SEED Caregiver Interview), self-report on the SEED maternal medical history form, and abstraction from prenatal medical records. | Children completed a multistage process. 1) Mother (mainly) completed the Social Communication Questionnaire. 2) Gold standard clinical assessments: Autism Diagnostic Observation Schedule, Autism Diagnostic Interview Revised, Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales. | Adjusted ORs were adjusted by the following variables: maternal age (continuous), maternal race, maternal education, family income, and smoking history. |
| Ames (Controls unexposed, sick), 2021 | case control | Maternal use of SSRIs during pregnancy were ascertained from all participants in three ways: self-report in a telephone interview shortly after study enrollment (SEED Caregiver Interview), self-report on the SEED maternal medical history form, and abstraction from prenatal medical records. | Children completed a multistage process. 1) Mother (mainly) completed the Social Communication Questionnaire. 2) Gold standard clinical assessments: Autism Diagnostic Observation Schedule, Autism Diagnostic Interview Revised, Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales. | Adjusted ORs were adjusted by the following variables: maternal age (continuous), maternal race, maternal education, family income, and smoking history. |
| Andersen (Controls unexposed, NOS), 2014 | population based cohort retrospective | Information on use of prescription medication was collected from the National Prescription Register (the Register of Medicinal Product Statistics), that contains individual-level data on all prescribed drugs dispensed at all pharmacies in Denmark. | The National Hospital Register was used to identified all registered cases of miscarriage (O021 and O03 according to the International Classification of Diseases, 10th Danish Revision) and induced abortion (ICD, 10th Danish Revision codes O04, O05 and O06). | Model adjusted for maternal age, number of previous miscarriages, income, year of outcome or censoring and educational length. |
| Andersen (Controls unexposed, sick), 2014 | population based cohort retrospective | Information on use of prescription medication was collected from the National Prescription Register (the Register of Medicinal Product Statistics), that contains individual-level data on all prescribed drugs dispensed at all pharmacies in Denmark. | The National Hospital Register was used to identified all registered cases of miscarriage (O021 and O03 according to the International Classification of Diseases, 10th Danish Revision) and induced abortion (ICD, 10th Danish Revision codes O04, O05 and O06). | Model adjusted for maternal age, number of previous miscarriages, income, year of outcome or censoring and educational length. |
| Anderson, 2020 | case control | Information on exposure to SSRIs and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants, conducted 6 weeks to 24 months after the EDD. | Case infants were ascertained through population-based birth-defects surveillance systems in 10 U.S. states. Controls were selected randomly from the same geographic areas. Clinical data were abstracted from medical records and classified by clinician geneticists and other clinicians. | Adjusted for maternal race/ ethnicity, prepregnancy body mass index, education, and early pregnancy smoking and alcohol use |
| Andrade, 2009 | retrospective cohort | Information on prescription drug dispensings was obtained from administrative databases at each health plan. | Hospitalization data for infants from the health plan administrative databases were used to identify cases of PPHN. For infants with one of these diagnosis or procedure codes, full-text hospital records were reviewed to confirm the diagnosis (blinded to drug exposure status). | Control matched 1:1 to those exposed to antidepressants by health plan, maternal age and year of admission for delivery. |
| Avalos (Controls exposed to TCA), 2015 | retrospective cohort (claims database) | Women exposed to antidepressant medications during pregnancy were identified through linkage to information on dates of drug dispensation and days of supply from the pharmacy database. | The diagnoses of preeclampsia and birth delivery data are available through KPNC's well-established automated clinical and pharmacy databases. Preeclampsia was defined as any of the following ICD-9 codes occurring after 20 weeks gestation: 642.4, 642.5, 642.6, or 642.7. | No adjustment for this group of comparison. |
| Avalos (Controls unexposed, disease free), 2015 | retrospective cohort (claims database) | Women exposed to antidepressant medications during pregnancy were identified through linkage to information on dates of drug dispensation and days of supply from the pharmacy database. | The diagnoses of preeclampsia and birth delivery data are available through KPNC's well-established automated clinical and pharmacy databases. Preeclampsia was defined as any of the following ICD-9 codes occurring after 20 weeks gestation: 642.4, 642.5, 642.6, or 642.7. | Adjusted for Pre-pregnancy BMI, maternal age, race/ethnicity, marital status, parity, alcohol use, smoking, diabetes, other indications for antidepressant medications, other mental health diagnoses. |
| Avalos (Controls unexposed, sick), 2015 | retrospective cohort (claims database) | Women exposed to antidepressant medications during pregnancy were identified through linkage to information on dates of drug dispensation and days of supply from the pharmacy database. | The diagnoses of preeclampsia and birth delivery data are available through KPNC's well-established automated clinical and pharmacy databases. Preeclampsia was defined as any of the following ICD-9 codes occurring after 20 weeks gestation: 642.4, 642.5, 642.6, or 642.7. | No adjustment for this group of comparison. |
| Bakaysa, 2016 | retrospective cohort | Not specified. | Not specified. | Matched to contemporary controls in a 2:1 fashion by completed weeks of gestation and mode of delivery. Fetal anomalies, stillbirths, and multiple gestations were excluded. |
| Bakker - Paroxetine, 2010 | case control | Information regarding medications dispensed before and during pregnancy is obtained from community pharmacies which keep complete records of dispersed medications. The use of the prescribed medications and the use of over-the-counter medication is verified in a telephone interview with the mother. | The registry is notified of infants and fetuses with a congenital malformation by physicians and midwifes on a voluntary basis. Reports are actively collected from obstetric, pediatric, pathology, cytogenetic departments. Data on malformations is obtained from the medical files and is coded (ICD). | Adjusted for year of birth. |
| Ban (Controls exposed to TCA), 2014 | retrospective cohort (claims database) | The Health Improvement Network (THIN), a nationally representative database that contains drug prescriptions. | All diagnoses of major congenital anomalies (MCAs) were identified in the children’s medical records using Read codes that we classified into 14 system-specific groups according to the European Surveillance of Congenital Anomalies (EUROCAT) subgroups. | No adjustment for this group of comparison. |
| Ban (Controls exposed to TCA), 2012 | population based cohort retrospective | Prescriptions of all antidepressants, hypnotics, and anxiolytics extracted of The Health Improvement Network (THIN) that contains electronic medical records. | The Health Improvement Network (THIN), a database of computerised primary care medical records | No adjustment for this group of comparison. |
| Ban (Controls unexposed, disease free), 2014 | retrospective cohort (claims database) | The Health Improvement Network (THIN), a nationally representative database that contains drug prescriptions. | All diagnoses of major congenital anomalies (MCAs) were identified in the children’s medical records using Read codes that we classified into 14 system-specific groups according to the European Surveillance of Congenital Anomalies (EUROCAT) subgroups. | Multivariable analyses were used to adjust for maternal age at the end of pregnancy, year of childbirth, Townsend deprivation quintile, maternal smoking history, body mass index before pregnancy, and maternal diabetes, hypertension, asthma, and epilepsy in the year before conception or during pregnancy. |
| Ban (Controls unexposed, disease free), 2012 | population based cohort retrospective | Prescriptions of all antidepressants, hypnotics, and anxiolytics extracted of The Health Improvement Network (THIN) that contains electronic medical records. | The Health Improvement Network (THIN), a database of computerised primary care medical records | Relative risk ratio adjusted for maternal age at the end of pregnancy, household socioeconomic status, maternal smoking status before delivery and body mass index before pregnancy. |
| Ban (Controls unexposed, sick), 2014 | retrospective cohort (claims database) | The Health Improvement Network (THIN), a nationally representative database that contains drug prescriptions. | All diagnoses of major congenital anomalies (MCAs) were identified in the children’s medical records using Read codes that we classified into 14 system-specific groups according to the European Surveillance of Congenital Anomalies (EUROCAT) subgroups. | Multivariable analyses were used to adjust for maternal age at the end of pregnancy, year of childbirth, Townsend deprivation quintile, maternal smoking history, body mass index before pregnancy, and maternal diabetes, hypertension, asthma, and epilepsy in the year before conception or during pregnancy. |
| Ban (Controls unexposed, sick), 2012 | population based cohort retrospective | Prescriptions of all antidepressants, hypnotics, and anxiolytics extracted of The Health Improvement Network (THIN) that contains electronic medical records. | The Health Improvement Network (THIN), a database of computerised primary care medical records | Relative risk ratio adjusted for maternal age at the end of pregnancy, household socioeconomic status, maternal smoking status before delivery and body mass index before pregnancy. |
| Batton, 2013 | retrospective cohort | SSRI prescription (or absence of such in controls) was documented in both the maternal antenatal records from the obstetrician’s office and the maternal hospital records. | Infant hospital records and the database of the Developmental Continuity Clinic (DCC) of the hospital were reviewed. In the DCC, each infant is examined by either the clinic director or psychologists (the Bayley Infant Neuro-developmental Screener (BINS) and the Bayley Scales of Infant Development). | Identified subjects were matched to controls by gestational age, year of birth, birth weight, gender, and age at neurodevelopmental assessment. |
| Benevent, 2023 | retrospective cohort (claims database) | Prescriptions obtained from the French Health Insurance database (Haute Garonne), that included all drug prescriptions dispensed at pharmacies by patients receiving outpatient care, prior to and during pregnancy (names, ATC codes, dispensing dates, etc). | Child outcomes obtained from the compulsory health certificates registered with the Maternal and Child Protection, from the Prenatal Diagnostic Center and the French National Uniform Hospital Discharge Data Set Database (PMSI) for maternal medical discharge diagnosis codes from hospital. | G. hypertension: adjusted for maternal age, parity, multiple pregnancy, gestational diabetes, history of diabetes, number of hospitalizations for depression, coprescription during pregnancy of medications, folic acid before pregnancy, prescription of drugs that could induce hypertension (NSAIDs, triptans and nasal vasoconstrictors) and assisted medical procreation.Other outcomes: none. |
| Bérard - Non Sertraline SSRI, 2015 | retrospective cohort (claims database) | Prescription fillings dispensed to women identified in the cohort from the Quebec public prescription drug insurance database. | Major congenital malformations were identified in the Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives (MedEcho) databases defined according to International Classification of Diseases (9th-10th). | Adjusted for maternal age, welfare status, diabetes, hypertension, asthma, and other medication use. |
| Bérard a, 2017 | population based cohort propective | The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration). | The Régie de l’assurance maladie du Québec (RAMQ) (diagnoses, medical procedures, ...), the hospitalization archive database (MedEcho: in-hospital diagnoses and procedures). PPHN defined as ICD-9: 416, 747.8 or ICD-10: I27, I521, P293. | Adjusted for maternal depression, use of antidepressants in the first 20 weeks of pregnancy and other potential confounders (sociodemographic variables, maternal chronic comorbidities during the 12 months prior to and during the first trimester of pregnancy). |
| Bérard b (Controls exposed to TCA), 2017 | retrospective cohort (claims database) | Prescription fillings for sertraline dispensed to women identified in the cohort from the Quebec public prescription drug insurance database | Major congenital malformations were identified in the Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives (MedEcho) databases defined according to International Classification of Diseases (9th-10th). | Adjusted for maternal age, welfare status, diabetes, hypertension, asthma and other medication uses including benzodiazepines as well as healthcare usage in the year prior and during the first trimester. |
| Bérard b (Controls unexposed, sick), 2017 | retrospective cohort (claims database) | Prescription fillings for sertraline dispensed to women identified in the cohort from the Quebec public prescription drug insurance database | Major congenital malformations were identified in the Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives (MedEcho) databases defined according to International Classification of Diseases (9th-10th). | Adjusted for maternal age, welfare status, diabetes, hypertension, asthma and other medication uses including benzodiazepines as well as healthcare usage in the year prior and during the first trimester. |
| Bernard, 2019 | prospective cohort | Documentation on antidepressant medication was obtained following delivery from a standardized prenatal follow-up form filled at each prenatal visit by the nurse and the physician and included in the hospital records. | Diagnosis of hypertensive disorders of pregnancy was made by a senior obstetrician based on information retrieved from medical records. | Adjusted for pre-pregnancy BMI, pre-pregnancy hypertension, maternal age, ethnicity, parity, smoking during pregnancy, mean arterial pressure (MAP) at the first visit, past history of hypertensive disorders of pregnancy, presence of gestational diabetes (GDM). |
| Bhatt-Mehta, 2019 | retrospective cohort | These patients were identified from the electronic health record (EHR) of the high-risk clinic based on use of either opioid. The search for simultaneous presence of SSRIs occurred when these records were reviewed in detail for concomitant medication prescriptions along with opioids. | Maternal records were linked postpartum to the corresponding infants admitted to the Neonatal intensive care unit (NICU). | None |
| Bliddal (Controls unexposed, NOS), 2023 | population based cohort retrospective | The Danish Prescription Register. | Information on psychiatric disorders was retrieved from the Danish National Patient Register, based on the Danish version of the International Classification of Diseases (ICD-10) and/or based on the Danish Prescription Register (prescription of SSRI, tricyclics or other antidepressants). | Adjusted by propensity score (PS) methods for maternal age, parity, body mass index, smoking, marital status, employment, highest education, income, children gender and birth year. Singletons only. |
| Bliddal (Controls unexposed, sick), 2023 | population based cohort retrospective | The Danish Prescription Register. | Information on psychiatric disorders was retrieved from the Danish National Patient Register, based on the Danish version of the International Classification of Diseases (ICD-10) and/or based on the Danish Prescription Register (prescription of SSRI, tricyclics or other antidepressants). | Adjusted by propensity score (PS) methods for maternal age, parity, body mass index, smoking, marital status, employment, highest education, income, children gender and birth year. Singletons only. |
| Boukhris (Controls exposed to TCA), 2016 | retrospective cohort (claims database) | The Public Prescription Drug Insurance database of Québec (drug name, start date, dose, and duration). Data on prescription filling for AD were validated against medical records and maternal reports. | The medical service databases: The Régie de l’assurance maladie du Québec (RAMQ): diagnoses, medical procedures, prescribers, and socioeconomic status of women and children), the Québec centralized hospitalization archives (MedEcho) and the Québec Statistics database. | No adjustment for this group of comparison. |
| Boukhris (Controls exposed to TCA), 2017 | retrospective cohort (claims database) | The Quebec’s Public Prescription Drug Insurance database (drug name, start date and duration), MedEcho database (diagnoses and procedures). | Administrative databases: the medical service database (RAMQ: diagnoses, therapeutic procedures), the Quebec Statistics database (ISQ) and prescription database. ADHD diagnosis was defined as a medical service claim or hospitalisation with a diagnosis of ADHD according to the ICD-9, ICD-10. | No adjustment for this group of comparison. |
| Boukhris (Controls unexposed, NOS), 2016 | retrospective cohort (claims database) | The Public Prescription Drug Insurance database of Québec (drug name, start date, dose, and duration). Data on prescription filling for AD were validated against medical records and maternal reports. | The medical service databases: The Régie de l’assurance maladie du Québec (RAMQ): diagnoses, medical procedures, prescribers, and socioeconomic status of women and children), the Québec centralized hospitalization archives (MedEcho) and the Québec Statistics database. | Singletons only. Adjusted for use of ADs 1 year before the first day of gestation, use of ADs in the first trimester, infant characteristics (sex, year of birth), and maternal variables (maternal age at first day of gestation, high school completed, recipient of social assistance, living alone, chronic or gestational hypertension, chronic or gestational diabetes, and other psychiatric disorders). |
| Boukhris (Controls unexposed, NOS), 2017 | retrospective cohort (claims database) | The Quebec’s Public Prescription Drug Insurance database (drug name, start date and duration), MedEcho database (diagnoses and procedures). | Administrative databases: the medical service database (RAMQ: diagnoses, therapeutic procedures), the Quebec Statistics database (ISQ) and prescription database. ADHD diagnosis was defined as a medical service claim or hospitalisation with a diagnosis of ADHD according to the ICD-9, ICD-10. | Adjusted for use of AD classes in the 1st trimester of pregnancy, infant characteristics (sex, year of birth), maternal variables (maternal age, level of education, recipient of social assistance, living alone, area of residence, chronic/gestational hypertension, chronic/gestational diabetes, other psychiatric disorders, maternal history of depression/anxiety, and maternal history of ADHD. |
| Boyle, 2017 | case control | Most sources of exposure data were prospective to outcome, except in one centre where exposure data are ascertained exclusively by interviewing mothers and clinicians after the congenital anomaly has been diagnosed; three other registries use maternal interviews to confirm their data. | EUROCAT registries that record all cases of major congenital anomalies among live births, foetal deaths ≥20 weeks’ gestation and termination of pregnancy for foetal anomaly (TOPFA), in their populations using International Classification of Diseases (ICD)-9/10. | Exclusion of teratogenic syndrome in both cases and controls. Exclusion of cases and controls exposed to diabetes. Adjusted for country and time. |
| Bracero, 2016 | retrospective cohort | The electronic medical system was queried for women on methadone maintenance. An electronic medical record review for data abstraction on both the mother’s and newborn’s medical records was performed. | An electronic medical record review for data abstraction on both the mother’s and newborn’s medical records was performed. | None. Exclusion of cases of multiple gestations. |
| Brennan, 2023 | retrospective cohort | Information on maternal prenatal antidepressants use was obtained from two sources in the ECHO database: the Maternal Medical Record Abstraction form (MMRA - medical records), and the Pregnancy Medical Conditions and Interventions (PMCI) questionnaire completed by the mothers (after delivery). | Autism spectrum disorder (ASD) diagnosis obtained from: established standardized diagnostic instruments, parental or other caregiver report of an ASD diagnosis, or diagnosis extracted from medical or educational records. Some mothers completed the Modified Checklist for Autism in Toddlers-Revised. | Covariates included the following maternal characteristics: maternal prenatal depression, age, education, race/ethnicity, marital status, prenatal substance use (tobacco, alcohol, marijuana), and pre-pregnancy BMI (obtained from medical record abstractions); as well as the child characteristics of age and sex. |
| Brown, 2017 | retrospective cohort (claims database) | Ontario Drug Benefit database. | Canadian Institutes of Health Information Discharge Abstract Database and Ontario Health Insurance Plan database. Autism spectrum disorder was defined as 2 or more outpatient diagnoses (by pediatrician or psychiatrist), 1 or more diagnoses in hospital databases after the age of 2 years, or both. | Use of a high-dimensional propensity score (HDPS) including 500 covariates. |
| Brown (Controls unexposed, disease free), 2016 | population based cohort retrospective | The drug reimbursement register that contains data on all reimbursed prescription drug purchases throughout Finland and covers virtually all prescription drug purchases (99% in 2007). | Data on diagnoses were derived from the Finnish Hospital Discharge Register (FHDR). These data were based on contact with Finnish specialized health services for developmental disorders but not from primary care. Diagnoses were based on (ICD-10) coding. | Group matched for date of birth. Adjusted for previous births, marital status, socioeconomic status, gestational age, exposure to antiepileptic drugs, mother's country of birth, parental death, smoking, maternal substance abuse, paternal age, maternal age, place of residence, exposure to anxiolytics/sedatives, entitlement to chronic diseases, maternal and paternal history of psychiatric diagnoses. |
| Brown (Controls unexposed, sick), 2016 | population based cohort retrospective | The drug reimbursement register that contains data on all reimbursed prescription drug purchases throughout Finland and covers virtually all prescription drug purchases (99% in 2007). | Data on diagnoses were derived from the Finnish Hospital Discharge Register (FHDR). These data were based on contact with Finnish specialized health services for developmental disorders but not from primary care. Diagnoses were based on (ICD-10) coding. | Adjusted for previous births, marital status, socioeconomic status, gestational age, exposure to antiepileptic drugs, mother's country of birth, parental death, smoking, maternal substance abuse, paternal age, maternal age, place of residence, exposure to anxiolytics/sedatives, entitlement to chronic diseases, maternal and paternal history of psychiatric diagnoses. |
| Calderon-Margalit, 2009 | prospective cohort | Participants were interviewed during a prenatal visit prior to 20 weeks of gestation by trained research personnel using a structured questionnaire. Data on medications used during pregnancy were retrieved from both questionnaires and medical records. | Information on pregnancy outcome was ascertained by reviewing hospital labor and delivery medical records and clinic records after delivery. | Adjustments for maternal age, race, years of education, marital status, smoking during pregnancy, preeclampsia, parity, and singleton/multiple pregnancy. |
| Cantarutti (Controls unexposed, NOS), 2016 | retrospective cohort (claims database) | The National Health Service (NHS) including a database concerning outpatient drug prescriptions reimbursed by the NHS and delivered by pharmacies in Lombardy; | The National Health Service (NHS) including a database reporting the Certificates of Delivery Assistance providing detailed information on the mother’s socioeconomic traits, as well as medical information on the pregnancy, childbirth, and child presentation at delivery. | Adjusted for maternal age, nationality, marital status, education, employment, previous miscarriages, parity, and medical conditions. |
| Cantarutti (Controls unexposed, sick), 2016 | retrospective cohort (claims database) | The National Health Service (NHS) including a database concerning outpatient drug prescriptions reimbursed by the NHS and delivered by pharmacies in Lombardy; | The National Health Service (NHS) including a database reporting the Certificates of Delivery Assistance providing detailed information on the mother’s socioeconomic traits, as well as medical information on the pregnancy, childbirth, and child presentation at delivery. | Adjusted for maternal age, nationality, marital status, education, employment, previous miscarriages, parity, and medical conditions. |
| Casper, 2003 | prospective cohort | Each woman completed a questionnaire that contained information about any drug exposure; the dose and timing of antidepressant drugs. | Delivery and neonatal course collected from obstetric and neonatal medical records. The child’s (6 months to 40 months) level of mental and motor development was tested by a clinical child psychologist by using the Bayley Scales of Infant Development, 2nd Edition (BSID-II). | None |
| Chambers, 2006 | nested case control | Within 6 months of delivery, trained study nurses who were unaware of the study hypothesis interviewed all the mothers. The structured telephone interview included questions on the use of all medications (prescription and over-the-counter) from 2 months before conception to the end of the pregnancy. | Admission and discharge records from major referral hospitals and clinics were reviewed, logbooks from neonatal intensive care units were examined, and weekly telephone calls were made to collaborators at newborn nurseries in community hospitals. | Infants who were matched with patients according to the hospital in which they were born and their date of birth. Odds ratios have been adjusted for maternal race or ethnic group, prepregnancy body-mass index, and diabetes. Further adjustment for other factors (e.g., smoking, alcohol intake, and use of NSAIDs after week 20) did not substantially change the results. |
| Chambers - Fluoxetine, 1996 | prospective cohort | Each woman who enrolled in the study completed a questionnaire that included notably exposures during the current pregnancy. Each woman was provided with a diary in which she was asked to keep a record of any additional exposures that might occur before delivery. | Birth outcome was recorded on a standard form completed by telephone interview with each mother shortly after delivery, and medical records were examined after their release. The infant’s physician was asked to return a form reporting the presence or absence of any major anomaly. | No adjustment for this group of comparison (adjusted for comparison with infants of women with early exposure). No statistical difference in terms of previous spontaneous abortions. |
| Chan (Controls exposed to TCA), 2024 | retrospective cohort (claims database) | Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | Diagnoses of malformations were determined by pediatricians, and were ascertained using the ICD-9-CM codes from specialist outpatient and inpatient records. | Exclusion of abnormalities due to maternal infection or exposure to known teratogens. No adjustment for this group of comparison. |
| Chan (Controls unexposed, general pop), 2024 | retrospective cohort (claims database) | Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | Diagnoses of malformations were determined by pediatricians, and were ascertained using the ICD-9-CM codes from specialist outpatient and inpatient records. | Exclusion of malfo due to maternal infection or exposure to known teratogens. Adjusted for age, parity, maternal pre-existing diseases (diabetes, hypertension, epilepsy...), gestational diabetes, hypertension, placental abnormalities, caesarean delivery, preterm delivery, maternal psychiatric disorders, substance/alcohol use disorders, medications (suspected teratogens, anticonvulsivant ...)... |
| Chan (Controls unexposed, sick), 2024 | retrospective cohort (claims database) | Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | Diagnoses of malformations were determined by pediatricians, and were ascertained using the ICD-9-CM codes from specialist outpatient and inpatient records. | Exclusion of malfo due to maternal infection or exposure to known teratogens. Adjusted for age, parity, maternal pre-existing diseases (diabetes, hypertension, epilepsy...), gestational diabetes, hypertension, placental abnormalities, caesarean delivery, preterm delivery, maternal psychiatric disorders, substance/alcohol use disorders, medications (suspected teratogens, anticonvulsivant ...)... |
| Chen, 2021 | population based cohort retrospective | The National Health Insurance Research Database (NHIRD) which is a medical claims database and that includes drug prescription. | The National Health Insurance Research Database (NHIRD) which is a medical claims database coding with ICD-9-CM codes. | Adjusted for age, income-related insurance premium, hospital types, urbanization levels, parity, multiple gestation, diabetes mellitus, hypertension, dyslipidemia, uteroplacental ischemia or hemorrhage, reproductive tract infection, (pre)eclampsia, placenta previa, abruptio placenta, polycystic ovaries, hypo- hypergonadism, history of infertility, morbid obesity or overweight, anxiety disorders. |
| Clements, 2015 | case control | The Partners HealthCare EHR includes medication data. | The Partners HealthCare EHR includes sociodemographic data, billing codes, laboratory results, problem lists, vital signs, procedure reports and narrative notes from hospitals which are part of the Partners HealthCare system, and affiliated outpatient clinics. | Model 1 is adjusted/matched for gender, race, birth year, insurance type, maternal age and median income tertile. Model 2 is adjusted for variables in model 1 and past history of maternal depression. |
| Cohen, 2022 | prospective cohort | Medication exposures were prospectively collected across pregnancy and the postpartum period (No other details). | Maternal subjects were each asked to complete a set of three questionnaires regarding her child(ren): Child Behavior Checklist (CBCL), Social Responsiveness Scale-2 (SRS-2), and Conners’ Revised Parent Rating Scale. Children were also tested in person for learning, memory, and executive functioning. | Infants born at term only. Age- and sex-matched controls. |
| Colvin, 2011 | retrospective cohort (claims database) | The national Pharmaceutical Benefits Scheme (PBS), including dispensing in the community, private hospitals, and, since late 2004, public hospitals. | The Western Australia Data Linkage System (WADLS): Hospital Morbidity Data System, the Midwives’ Notification System, the Registry of Births and Deaths, and the Birth Defects Registry. | Preterm adjusted for previous preterm birth, smoke, Socio-Economic Indexes for Areas, parity, maternal age. |
| Colvin, 2012 | retrospective cohort (claims database) | The national Pharmaceutical Benefits Scheme (PBS), a claims database that includes 80% of all prescriptions dispensed in Australia. | The Western Australia Data Linkage System (WADLS), which contains data from the Hospital Morbidity Data System, the Midwives’ Notification System, the WA Registry of Births and Deaths and the WA Register of Developmental Anomalies. The ICD-10-AM is used. | Preterm adjusted for a previous preterm birth, smoking, SEIFA (Socio-Economic Indexes for Areas), parity and maternal age, and considering only singletons. LBW adjusted for gestational age, whether the mother smoked during her pregnancy, SEIFA, sex, parity and maternal height. |
| Cornet - SSRIs, 2024 | retrospective cohort (claims database) | Prescription files of Kaiser Permanente Northern California pharmacies. For each prescription, dispensation date, daily dosage and number of pills dispensed were collected. | Maternal, pregnancy and neonatal data were obtained from electronic medical records of Kaiser Permanente Northern California. | Term infants only. Exclusion of infants with congenital anomalies or genetic abnormalities. Adjusted for maternal age, race/ethnicity, state-subsidized insurance, nulliparity; anxiety or depression during pregnancy, maximal PHQ-9 score, non-SSRI antidepressant/antipsychotic, positive pregnancy toxicology screen, cannabis use; chronic hypertension, type 2 diabetes and infant sex. |
| Corti, 2019 | prospective cohort | Pregnancies were prospectively enrolled. All exposed pregnancies were followed in a prospective way by our multidisciplinary team, that checked drug compliance at each visit during the whole pregnancy up to delivery. Unexposed: the first two deliveries immediately after each SSRI exposed. | Maternal and fetal data of the control group were collected from the registers and databases of Sacco Hospital. Pregnancy complications and neonatal anthropometric characteristics were evaluated. | None. Exclusion criteria for both groups were other psychotropic drugs, anti-epileptics, drug of abuse, alcohol addiction, maternal or fetal infectious diseases, fetal/neonatal chromosomal genetic abnormalities. The population was homogenous for demographic, anthropometric, socio-economic and obstetric variables except for smoking and mean hemoglobin values before delivery. |
| Costei - Paroxetine (Controls unexposed, NOS), 2002 | prospective cohort | At the time of counseling (during pregnancy), detailed exposure data and information on all other drugs used concomitantly were collected by maternal interview. | After delivery, participants were contacted again to record the pregnancy outcome and neonatal complications, including withdrawal symptoms and breastfeeding. | Controls were matched for maternal age, gravity, parity, social drug use (alcohol and smoking), and nonteratogenic drug use (eg, acetaminophen, vitamins, and calcium supplements). Pregnant women who received other drugs known to cause withdrawal-type symptoms, such as opioids or benzodiazepines, were excluded. |
| Costei - Paroxetine (Controls unexposed, sick), 2002 | prospective cohort | At the time of counseling (during pregnancy), detailed exposure data and information on all other drugs used concomitantly were collected by maternal interview. | After delivery, participants were contacted again to record the pregnancy outcome and neonatal complications, including withdrawal symptoms and breastfeeding. | Controls were matched for maternal age, gravity, parity, social drug use (alcohol and smoking), and nonteratogenic drug use (eg, acetaminophen, vitamins, and calcium supplements). Pregnant women who received other drugs known to cause withdrawal-type symptoms, such as opioids or benzodiazepines, were excluded. |
| Croen, 2011 | nested case control | All inpatient and outpatient prescriptions for antidepressants dispensed at a KPNC pharmacy in the 3 months before the last menstrual period (LMP) through the date of delivery of the study child were identified from the Pharmacy Information Management System. | On the basis of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) recorded in the KPNC outpatient clinical databases. | Controls matched to case children by sex, birth year, and hospital of birth. Adjusted for age (continuous), race/ethnicity, and education of mother; birth weight (continuous), sex, and birth year of child, birth facility, and mother’s history of any mental health disorders in year before delivery. |
| Dandjinou, 2019 | nested case control | The Quebec Prescription Drug Insurance Database (drug name, start date, dosage and duration). | The medical service database (RAMQ: diagnoses and medical procedures), the Hospitalisation Archive Database (MedEcho: in-hospital diagnoses and procedures) and the Quebec Statistics Database (Institut de la statistique du Québec (ISQ):patient sociodemographic information). | Matched for gestational age and year of pregnancy. Adjusted for maternal age, area of residence, receipt of social assistance during pregnancy, physician-based diagnoses or filled prescriptions of medications for chronic comorbidities; physician-based diagnoses of maternal diseases; medication use other than antidepressants; history of antidepressant use and health service utilisation. |
| Dave, 2019 | nested case control | The IBM MarketScan commercial claims database, an employer-sourced health insurance database. | Neonatal abstinence syndrome deliveries were identified using in- and outpatient encounters with the ICD-9 code 779.5 within 30 days of delivery date in either the infant or mother’s medical encounter files. | Adjusted for secular trends, age at delivery, antepartum use of five psychotropic drug classes commonly linked to NAS, and other risk factors associated with NAS (Opioid-use disorder, smoking). Exclusion of conditions related to iatrogenic NAS (intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, spontaneous intestinal perforation or bronchopulmonary dysplasia). |
| Davidson, 2009 | retrospective cohort | A detailed questionnaire covering medications during pregnancy was completed for each participant after delivery. | A detailed questionnaire covering anthropometry and medical illnesses was completed for each participant after delivery. In all infants, anthropometric parameters were measured according to the routine procedure. The control infants were examined once a day by one of the authors until discharge. | Singletons only. The two groups were matched for gestational age (1 wk). Women with diabetes, chronic hypertension, and cardiovascular diseases were excluded from participation in the study. Non significant difference in Body mass index, maternal age, gravidy, parity or smoking habits between the 2 groups. |
| Davis, 2007 | retrospective cohort (claims database) | Information on prescribed antidepressant medications was derived from the pharmacy database files available at each health system. | Information on patient age, health plan enrollment status, and inpatient and outpatient diagnoses and procedures was obtained from automated databases at each health system. Assessment of outcomes was limited to assigned ICD9 codes except for 3 malfo where medical charts were reviewed. | None. |
| De Jonge - Paroxetine only, 2013 | case control | For controls: from the IADB, a population-based prescription database. For cases: the pharmacy records for 3 months before conception until delivery were obtained and verified in a telephone interview and only the actually used medication is registered. | Information on congenital malformations is obtained from the medical files, including pathology reports, and coded afterwards, according to the International Classification of Diseases (ICD) coding system by trained registry staff. | None |
| De Ocampo, 2016 | prospective cohort | After enrollment, the women completed a comprehensive intake interview and use of prescription and over-the-counter medications were collected. Information on exposures collected at intake was updated at each successive interview (every 3 months until the end of the pregnancy). | Outcomes were self-reported by the participants at any interview after 20 weeks of gestation and for a minimum of 1 year after birth. Additional data, such as birth outcomes, were also collected from medical records obtained from the obstetrician, birth hospital, and the child’s pediatrician. | Adjusted for race/ethnicity, parity, diabetes status, asthma status, autoimmune disease status, cigarettes smoked per day, maternal age, pre- pregnancy BMI, gravidity, cohort study, and enrollment year |
| De Vera, 2012 | nested case control | The Quebec’s Public Prescription Drug Insurance Plan. | Linkage of three administrative databases: (i) Régie de l’Assurance Maladie du Québec (RAMQ), (ii) MED-ECHO and (iii) Institut de la Statistique du Québec (ISQ). | Cases and controls matched on gestational age. Multivariable models were adjusted for sociodemographic variables, depression, anxiety, other comorbid medical conditions, medication use and health care utilization. |
| de Vries, 2013 | prospective cohort | Women, in any stage of pregnancy and in both groups, were either self-referred, after reading about our study in the local newspapers, or referred by their gynaecologist, psychiatrist, midwife, or general practitioner. | Quality of an infant’s general movements (GMs) was assessed according to Prechtl’s method at the outpatient clinic or at home by either author CV or research assistant. Analysis performed by 2 authors that were blind as to the infants’ exposure status to SSRI. | Adjusted for maternal depression during 3rd trimester, low-level maternal education (lower than vocational education), gestational age below 38 weeks, birth weight below 2750 g, and sex. |
| Diav-Citrin - Fluoxetine or Paroxetine, 2008 | prospective cohort | Details of exposure were collected at the initial contact with the TIS and before pregnancy outcome was known using a structured questionnaire. SSRIs and other exposures were also ascertained after delivery. | Follow-up was con- ducted by a telephone interview or mailed questionnaire to the woman or the child’s paediatrician to obtain details of the pregnancy outcome, gestational age at delivery, birth weight, congenital anomalies and neonatal complications. | Adjusted for gestational age at call, maternal age, smoking, TIS origine, concomitants psychiatric medication, multi fetal gestation, SSRI dose. |
| Dubnov-Raz, 2008 | prospective cohort | Not specified. | For the neontates outcomes their medical charts and ECG tracings were extracted. For the purpose of this study, ECGs were interpreted by a single experienced pediatric cardiologist (Dr Fogelman), who was blinded to drug exposure. | Controls matched on gestational age. Exclusion of neonates born to women treated with any other chronic medication during pregnancy (whether known as QT prolonging or not), with gestational diabetes or hypothyroidism, with Apgar scores <7 (either 1 or 5 minutes) and those with cardiac structural abnormalities identified by echocardiography. |
| Edelson, 2020 | retrospective cohort | Medication regimens were ascertained by chart review. | Obstetric and neonatal outcomes were ascertained by chart review. Neonatal abstinence syndrome (NAS) was diagnosed using Modified Finnegan Scores. | No adjustment. Singleton pregnancy without prenatally diagnosed genetic abnormalities or malformations. No demographic differences, nor were there any differences in the rates of known potential confounders for NAS severity: benzodiazepine use, gabapentin use, tobacco use, birthweight, gestational age or male sex (not shown). |
| Einarson, 2001 | prospective cohort | On successful contact, information on each woman’s exposure history and pregnancy outcome were obtained, along with other measures of interest, with the aid of a structured questionnaire. | At follow-up, women were questioned regarding the course of their pregnancy, the health of their child. Outcomes were confirmed by sending a letter to the child’s primary care physician to corroborate the mother’s information. | None |
| Einarson, 2009 | prospective cohort | During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire. | At the follow-up interview, gestational findings, fetal outcomes, and neonatal health are documented on a structured form by telephone interview with each mother. The details are then corroborated with the report of the physician caring for the baby. | The 2 whole groups were matched for maternal age, smoking, and alcohol use. But no matching for selective serotonin reuptake inhibitors (SSRIs). |
| Einarson - Paroxetine, 2008 | prospective cohort | During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire form. Details about the exposure include duration, timing in pregnancy, dose, frequency, and medical indication for use of the drug. | At the follow-up interview, gestational findings and fetal outcomes are documented on a structured, standardized form by telephone interview. With the mother’s permission, this report is corroborated with the report of the physician caring for the baby. | None. |
| El Marroun (Control unexposed, disease free), 2014 | prospective cohort | Exposure to Selective serotonin reuptake inhibitors (SSRIs) was assessed during pregnancy, using two sources of information: (a) self-report assessed with questionnaires and (b) prescription records from pharmacies. | Autistic symptoms were parent-reported using two instruments: the pervasive developmental problems subscale of the Child Behavior Checklist for ages 1.5–5 (CBCL 1.5–5) and the Social Responsiveness Scale (SRS). | Model I was adjusted for maternal age at intake, gender of the child, maternal education, ethnicity, maternal smoking habits and gestational age at birth. Model II was additionally adjusted for maternal depressive symptoms at 3 years. |
| El Marroun (Control unexposed, sick), 2014 | prospective cohort | Exposure to Selective serotonin reuptake inhibitors (SSRIs) was assessed during pregnancy, using two sources of information: (a) self-report assessed with questionnaires and (b) prescription records from pharmacies. | Autistic symptoms were parent-reported using two instruments: the pervasive developmental problems subscale of the Child Behavior Checklist for ages 1.5–5 (CBCL 1.5–5) and the Social Responsiveness Scale (SRS). | Model I was adjusted for maternal age at intake, gender of the child, maternal education, ethnicity, maternal smoking habits and gestational age at birth. Model II was additionally adjusted for maternal depressive symptoms at 3 years. |
| El Marroun (Controls unexposed, disease free), 2012 | prospective cohort | Maternal SSRI use during pregnancy assessed by 2 sources of information: (1) self-reports assessed with questionnaires and (2) prescription records from pharmacies. In each trimester, participants reported whether they had used any medication. | Fetal ultrasonography was performed in each trimester. Gestational age and weight at birth were extracted from medical records. | All analyses were adjusted for body mass index, educational level, maternal smoking habits, maternal age, ethnicity, fetal sex, parity, and maternal use of benzodiazepines, but not maternal drinking habits and cannabis use because these variables did not change the observed associations. |
| El Marroun (Controls unexposed, sick), 2012 | prospective cohort | Maternal SSRI use during pregnancy assessed by 2 sources of information: (1) self-reports assessed with questionnaires and (2) prescription records from pharmacies. In each trimester, participants reported whether they had used any medication. | Fetal ultrasonography was performed in each trimester. Gestational age and weight at birth were extracted from medical records. | No adjustment for this group of comparison. |
| Engelstad (Controls unexposed, disease free), 2014 | retrospective cohort | The use of antidepressants during pregnancy was identified based on medication record and medical chart review. | The admission notes, progress notes, and discharge notes of infants born to selected mothers were reviewed during the delivery encounter. | Multivariate model including tobacco use, obesity, and diagnosis of depression (and alcohol ?). |
| Engelstad (Controls unexposed, sick), 2014 | retrospective cohort | The use of antidepressants during pregnancy was identified based on medication record and medical chart review. | The admission notes, progress notes, and discharge notes of infants born to selected mothers were reviewed during the delivery encounter. | No adjustment for this group of comparison. |
| Eriksson, 2012 | case control | Data on maternal pre- and intrapregnancy medication were collected from the Swedish medical birth register (SMBR) and the Statistical Central Bureau of Sweden. | All children were assessed by one of four medical doctors in the research team. The parents were comprehensively interviewed according to a structured protocol regarding first-degree relatives with ASD and other neurodevelopmental problems and/or a history of psychiatric disorder. | None. |
| Figueroa, 2010 | retrospective cohort (claims database) | The MarketScan data contain information including prescription claims and the date of the service. | Outpatient and inpatient claims with a primary or secondary diagnosis of ADHD and prescription claims for stimulants, determined by national drug coding, were identified. | Controlled for demographic and perinatal factors (including maternal age group, gender of the child, urban or rural metropolitan statistical area, year of birth, and age at last claim and at end of eligibility), parental mental health diagnoses, the use of other psychotropics during pregnancy, and maternal mental health visits by year of the child’s life. |
| Frayne, 2021 | retrospective cohort | Psychotropic medication usage was extracted from the medical records and included information for first trimester and third trimester exposure as well as dosage. | Data were extracted from a large dataset utilising the hospital medical records. | No adjustment for this group of exposure. |
| Furu (Controls unexposed, NOS), 2015 | population based cohort retrospective | The Nordic prescription registers include data on dispensed drugs, substance, brand name, and formulation, together with date of dispensing. | From the medical birth, patient, and malformation registers data on maternal characteristics, the pregnancy and delivery, and major birth defects were retrieved. | Adjusted for maternal age, year of birth, birth order, smoking, maternal diabetes, country, and use of other prescribed drugs (antiepileptics (atC code n03), anxiolytics and hypnotics (n05b and n05C), and angiotensin converting enzyme inhibitors (C09)). |
| Furu (Controls unexposed, sibling), 2015 | population based cohort retrospective | The Nordic prescription registers include data on dispensed drugs, substance, brand name, and formulation, together with date of dispensing. | From the medical birth, patient, and malformation registers data on maternal characteristics, the pregnancy and delivery, and major birth defects were retrieved. | Sibling design. Adjusted for maternal age, year of birth, birth order, smoking, maternal diabetes, country, and use of other prescribed drugs (antiepileptics (atC code n03), anxiolytics and hypnotics (n05b and n05C), and angiotensin converting enzyme inhibitors (C09)). |
| Galbally (Controls unexposed, disease free), 2020 | prospective cohort | Antidepressant type, usage, dosage and timing during pregnancy was self-reported by women at each time point, as well as obtained from hospital records at delivery and drug levels in maternal and cord blood. | Pregnancy complications collected from women and verified in hospital record. The Brief Infant Sleep Questionnaire (BISQ) was administered to mothers. Parenting was assessed using the Parenting Stress Index, Short-form (PSI-4-SF). The Ages and Stages Questionnaire (3rd Ed.) completed by parents. | ASQ: Models adjusted for maternal university education and age at recruitment, infant gender, and maternal EPDS score and infant age at time of ASQ assessment. |
| Galbally (Controls unexposed, sick), 2020 | prospective cohort | Antidepressant type, usage, dosage and timing during pregnancy was self-reported by women at each time point, as well as obtained from hospital records at delivery and drug levels in maternal and cord blood. | Pregnancy complications collected from women and verified in hospital record. The Brief Infant Sleep Questionnaire (BISQ) was administered to mothers. Parenting was assessed using the Parenting Stress Index, Short-form (PSI-4-SF). The Ages and Stages Questionnaire (3rd Ed.) completed by parents. | ASQ: Models adjusted for maternal university education and age at recruitment, infant gender, and maternal EPDS score and infant age at time of ASQ assessment. |
| Giardinelli (Controls unexposed, disease free), 2018 | prospective cohort | Pregnant women were exposed to pharmacotherapy according to the severity of depression diagnosed in the clinic for perinatal mental health at the University of Florence. | Fetal ultrasonography assessments performed in the 2nd and 3rd trimesters in order to assess fetal growth characteristics. The crown-rump length, femur length, abdominal circumference and head circumference were measured using standardized procedures. | None |
| Giardinelli (Controls unexposed, sick), 2018 | prospective cohort | Pregnant women were exposed to pharmacotherapy according to the severity of depression diagnosed in the clinic for perinatal mental health at the University of Florence. | Fetal ultrasonography assessments performed in the 2nd and 3rd trimesters in order to assess fetal growth characteristics. The crown-rump length, femur length, abdominal circumference and head circumference were measured using standardized procedures. | None |
| Given, 2017 | case control | First trimester maternal medication exposures were mostly obtained by registries from prospectively recorded maternity records. Additional data sources included the medical records of the infant, general practitioner records, maternity passports, and maternal interviews before or after birth. | EUROCAT registries that record all cases of major congenital anomalies among live births, foetal deaths ≥20 weeks’ gestation and termination of pregnancy for foetal anomaly (TOPFA), in their populations using International Classification of Diseases (ICD)-9/ | Adjustment for maternal age group, registry and time period. Excluding diabetes and anti-epileptic medication exposed. |
| Gover, 2023 | retrospective cohort | Data were retrospectively collected from an electronic health record database (Metavision®, iMDsoft). Records were reviewed using MetaVision’s Query Wizard tool, identifying infants admitted to neonatal intensive care unit with completed data on maternal drug use during pregnancy. | Data were retrospectively collected from an electronic health record database (Metavision®, iMDsoft). Records were reviewed using MetaVision’s Query Wizard tool, identifying infants admitted to neonatal intensive care unit. All identified infant records were then reviewed to select the preterm. | Matched by gestational age, birth weight, sex and date of birth. Infants with culture-positive early-onset sepsis, maternal diabetes, major or genetic malformations, who did not survive the first week of life, with unknown maternal drug history or additional psychotropic medications or those in whom maternal SSRI use was discontinued before the third trimester were excluded. |
| Granstrom, 2019 | nested case control | The exposure was assessed through the Swedish Prescribed Drug Register for both cases and their mothers, that contains information on drug identity (Anatomical Therapeutic Chemical (ATC) codes) and dates of all registered prescriptions to the entire population in Sweden. | The outcome was assessed through linkage with the Swedish National Patient Register (NPR) and the Swedish Medical Birth Register (MFR) for both cases and their mothers. The International Classification of Diseases (ICD) codes was used. | For each case, five controls, matched for birth year and gender. |
| Grzeskowiak (Controls unexposed, disease free), 2013 | population based cohort retrospective | At the time of providing consent, women were asked to report on medication use during early pregnancy in a self-administered questionnaire (at approx. 6-10 weeks of gestation). Information on drug use was also obtained from the 2 other women telephone interviews during pregnancy. | A self-administered questionnaire completed by parents was used to follow-up children at the age of 7 years. | Adjusted for maternal age, smoking status, pre-existing diabetes, gestational diabetes, pre-pregnancy maternal BMI, paternal BMI and also for neonatal birth weight, weight gain during pregnancy, breastfeeding, and postnatal distress. |
| Grzeskowiak (Controls unexposed, sick), 2013 | population based cohort retrospective | At the time of providing consent, women were asked to report on medication use during early pregnancy in a self-administered questionnaire (at approx. 6-10 weeks of gestation). Information on drug use was also obtained from the 2 other women telephone interviews during pregnancy. | A self-administered questionnaire completed by parents was used to follow-up children at the age of 7 years. | Adjusted for maternal age, smoking status, pre-existing diabetes, gestational diabetes, pre-pregnancy maternal BMI, paternal BMI and also for neonatal birth weight, weight gain during pregnancy, breastfeeding, and postnatal distress. |
| Grzeskowiak a (Controls unexposed, disease free), 2012 | retrospective cohort | Data on exposure to SSRIs during pregnancy were obtained from the Women’s and Children’s Hospital (WCH) Pharmacy Dispensing Records, which is a record of all medications dispensed. | Data are collected from each woman’s medical records after delivery by a specially trained research midwife, including pregnancy complications, and newborn characteristics (eg, birth weight). | Confounders considered a priori were maternal age, race, socioeconomic status, parity, smoking status, alcohol abuse, substance use, anxiolytic use, and chronic medical conditions including, preexisting diabetes, thyroid disorder, hypertension, and epilepsy. In addition, preterm delivery was adjusted for previous history of preterm delivery, and low birth weight was adjusted for maternal height. |
| Grzeskowiak a (Controls unexposed, sick), 2012 | retrospective cohort | Data on exposure to SSRIs during pregnancy were obtained from the WCH Pharmacy Dispensing Records, which is a record of all medications dispensed. | Data are collected from each woman’s medical records after delivery by a specially trained research midwife, including pregnancy complications, and newborn characteristics (eg, birth weight). | Confounders considered a priori were maternal age, race, socioeconomic status, parity, smoking status, alcohol abuse, substance use, anxiolytic use, and chronic medical conditions including asthma, preexisting diabetes, thyroid disorder, and epilepsy. In addition, preterm delivery was adjusted for previous history of preterm delivery, and low birth weight was adjusted for maternal height. |
| Grzeskowiak b (Controls unexposed, disease free), 2012 | retrospective cohort | Data on exposure to SSRIs during pregnancy were obtained from the WCH Pharmacy Dispensing Records, which is a record of all medications dispensed. | Electronic records of the Women’s and Children’s Health Network (WCHN) Child Health Record were used to obtain follow-up data on child weight and height. | Adjusted for maternal age, socioeconomic status, smoking status, race, parity, maternal body mass index, foetal growth and breastfeeding status at discharge from hospital. |
| Grzeskowiak b (Controls unexposed, sick), 2012 | retrospective cohort | Data on exposure to SSRIs during pregnancy were obtained from the WCH Pharmacy Dispensing Records, which is a record of all medications dispensed. | Electronic records of the Women’s and Children’s Health Network (WCHN) Child Health Record were used to obtain follow-up data on child weight and height. | Adjusted for maternal age, socioeconomic status, smoking status, race, parity, maternal body mass index, foetal growth and breastfeeding status at discharge from hospital. |
| Gungor (Controls exposed to Mirtazapine), 2019 | prospective cohort | Patient pregnant women were followed naturalistically throughout their pregnancy. The psychiatric medication and use of other medications were documented in every individual visit. | After delivery, the medical records of the baby were recorded. | None |
| Gungor (Controls unexposed, disease free), 2019 | prospective cohort | Patient pregnant women were followed naturalistically throughout their pregnancy. The psychiatric medication and use of other medications were documented in every individual visit. | After delivery, the medical records of the baby were recorded. | None |
| Gungor (Controls unexposed, sick), 2019 | prospective cohort | Patient pregnant women were followed naturalistically throughout their pregnancy. The psychiatric medication and use of other medications were documented in every individual visit. | After delivery, the medical records of the baby were recorded. | None |
| Hagberg (Controls exposed to TCA), 2018 | retrospective cohort (claims database) | The UK Clinical Practice Research Datalink (CPRD) where participating general practitioners (GPs) contributed de-identified data including details of prescription drugs. | Diagnosis in the UK Clinical Practice Research Datalink (CPRD) with at least one Read diagnostic code indicating ASD recorded at any time, including codes for autism, Asperger’s syndrome, and pervasive developmental disorder (PDD). | No adjustment for this group of comparison. |
| Hagberg (Controls unexposed, disease free), 2018 | retrospective cohort (claims database) | The UK Clinical Practice Research Datalink (CPRD) where participating general practitioners (GPs) contributed de-identified data including details of prescription drugs. | Diagnosis in the UK Clinical Practice Research Datalink (CPRD) with at least one Read diagnostic code indicating ASD recorded at any time, including codes for autism, Asperger’s syndrome, and pervasive developmental disorder (PDD). | Adjusted for maternal BMI, smoking status, parity, anxiety, or other psychiatric dis- orders. Matched on mother’s year of birth (±2 years), baby’s year of birth (±2 years), and general practice attended. |
| Hagberg (Controls unexposed, sick), 2018 | retrospective cohort (claims database) | The UK Clinical Practice Research Datalink (CPRD) where participating general practitioners (GPs) contributed de-identified data including details of prescription drugs. | Diagnosis in the UK Clinical Practice Research Datalink (CPRD) with at least one Read diagnostic code indicating ASD recorded at any time, including codes for autism, Asperger’s syndrome, and pervasive developmental disorder (PDD). | No adjustment for this group of comparison. |
| Handal a, 2016 | population based cohort propective | The mothers received three questionnaires with questions regarding drug use before and during pregnancy: during pregnancy (week 17/18 and week 30) and 6 months after birth. | Motor skills at the age of 3 years were assessed through maternal ratings on selected items from the Ages and Stages Questionnaire (ASQ). | Adjusted for depression before pregnancy, symptoms of anxiety and depression in pregnancy, parental education, paternal age, parity, maternal smoking, prepregnancy Body mass index. |
| Hanley, 2016 | retrospective cohort (claims database) | The British Columbia PharmaNet (a prescription dispensation database into which all prescriptions dispensed must be entered by law). | The Population Data British Columbia with all medical services records, all hospital discharge records. Hospital records over the period of study included diagnostic codes based on the ICD-9 and ICD-10: Women with diagnostic codes for postpartum hemorrhage (ICD-9 666.x and ICD- 10 O72.x). | Adjusted for year of birth, maternal age, parity, preterm birth, multifetal pregnancy, diabetes, coagulopathy, smoking during pregnancy, blood thinner use in the month before delivery, anxiolytic use in the month before delivery, antipsychotic use in the month before delivery, a diagnosis of mood disorder, any psychiatric visits, or any psychiatric hospitalization in the 5 months before delivery. |
| Hannerfors (Controls unexposed, NOS), 2015 | retrospective cohort | The study subjects complete web-based self-administrated structured questionnaires containing questions on ongoing medication. The medical records of the women who were on SSRI were reviewed to verify the self-reported SSRI use and to ensure that SSRI had been used during the entire pregnancy. | The medical records of all women were reviewed to ascertain important information on obstetric and perinatal variables. | Adjustment for preterm: adjusted for parity, smoking, Body mass index, chronic hypertension, maternal country of origin, and gestational age at sampling. |
| Hannerfors (Controls unexposed, sick), 2015 | retrospective cohort | The study subjects complete web-based self-administrated structured questionnaires containing questions on ongoing medication. The medical records of the women who were on SSRI were reviewed to verify the self-reported SSRI use and to ensure that SSRI had been used during the entire pregnancy. | The medical records of all women were reviewed to ascertain important information on obstetric and perinatal variables. | None |
| Harrington, 2014 | case control | A standardized telephone interview was conducted with the child’s biological mother to collect exposures for an index period covering 3 months before conception to the end of pregnancy or through breastfeeding. Prenatal medical records were used, when available, to supplement self-reported SSRI use. | Children with ASD and DD were identified from those qualifying for specific services. To confirm ASD diagnoses, children were assessed with the Autism Diagnostic Interview–Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) by trained staff with reliability on the instruments. | Controls matched to autism cases by age, gender (targeted 4:1 male:female ratio), and regional center. Adjusted for regional center, child’s year of birth, and birthplace of mother. |
| Hartwig, 2022 | case control | Prescription database that contains prescription records include data on the date of dispensing, the amount dispensed, the dose regimen, the number of days the prescription is valid, the prescribing physician, and the Anatomical Therapeutic Chemical (ATC) code. | Drug prescription data was used as a proxy for Attention-deficit/hyperactivity disorder (ADHD) in offspring, as diagnostic information was not available: methylphenidate (MPH), dextroamphetamine or atomoxetine. | Singleton pregnancies. Adjusted for birth date of the child (as proxy for the date of pregnancy), age of the parent at birth, use of psychostimulants, opioids, and use of antiepileptic drugs in the 15 months before delivery. |
| Heikkinen - Citalopram only, 2002 | prospective cohort | Blood samples (5 mL) for the analysis of plasma concentrations of citalopram and its two metabolites, desmethyl- citalopram and didesmethylcitalopram, were taken at each of the 3 visits (during pregnancy). | At delivery, the infants were submitted to a standardized investigation (birth weight, Apgar, ...) and a more detailed clinical examination was performed on day 2 by a pediatrician and a physiotherapist. The development of the infant was followed by pediatrician and physiotherapist examinations. | Controls matched for confounding obstetric characteristics: age, gravidity, parity, and time and mode of delivery. |
| Heikkinen - Fluoxetine only, 2003 | prospective cohort | Pregnant women taking fluoxetine recruited (NOS). Fluoxetine concentrations detected from the blood samples during gestation (at the last visit: 36-37 weeks of gestation). | At the time of delivery, the birth weight, Apgar score, umbilical artery pH (...) were routinely recorded. A neurologic examination was performed by a pediatrician and a physiotherapist, at the corrected ages of 2 weeks and 2, 6, and 12 months. | Control group matched for confounding obstetric characteristics (age, gravidity, parity, gestational weeks, and mode of delivery) at the time of delivery. |
| Heinonen - Sertraline, 2021 | randomized controlled trial | The women were either randomized to sertraline or placebo with the daily dose starting at one capsule á 25 mg. Plasma sertraline and desmethylsertraline concentrations in the mothers were measured once in the second trimester and once in the third trimester. | The babies were monitored with the modified Neonatal Abstinence Scale (NAS) according to Finnegan during their first 48 h of life. | No adjustment. Randomisation. |
| Heuvelman, 2023 | retrospective cohort (claims database) | The Clinical Practice Research Datalink (CPRD) contains an extensive code list to identify the name, formulation and dose of medications, which are mandatory fields in the prescription electronic record (according to protocol). | For child outcomes, the primary care clinical and referral records were examined for presence of disorders based on Read codes and for ADHD: prescription of ADHD medication (methylphenidate, dexamphetamine, atomoxetine, dextroamphetamine, amphetamine with dexamphetamine, or lisdexamphetamine). | Adjusted for maternal age, Charlson Comorbidity Index score, maternal disorders (alcohol-related, psychosis, anxiety, self-harm, bipolar disorder, eating disorders, personality disorders, sleep disorders and neuropathic pains), medications (for physical health problems, central nervous system agents, multiple antidepressants ...) smoking, any recorded severity of past depressive symptoms... |
| Hogue, 2017 | retrospective cohort | Review of electronic medical records. Each participant’s obstetric visits for prenatal care, medication histories, and other inpatient notes were reviewed to ensure the neonate was exposed to one of the study medications during pregnancy. | Review of electronic medical records. Gestational age was taken from obstetric history as it was calculated by ultrasound. | Propensity score using a multivariable logistic regression with neonatal factors (gender, race, delivery type, year of birth, birth length, birth weight and gestational age) and maternal factors (prenatal care visits, diabetes, hypertension, preeclampsia, other significant comorbidities, alcohol use, tobacco use, use of potentially harmful medications, magnesium sulfate, steroids, age and parity). |
| Hutchison a, 2019 | prospective cohort | Not specified (mothers recruited during their second trimester of pregnancy). | Gross motor skills assessed using the Bayley Scales of Infant Development. Child physical activity: Recreational Activities section of the MacArthur Health and Behavior Questionnaire (HBQ-P) completed by mothers. Trained research staff measured children’s height, weight, and waist circumference. | None |
| Hutchison b, 2019 | prospective cohort | Mothers recruited during their second trimester of pregnancy. | Post-hoc analyses to examine the negativity scale on the Behavior Rating Inventory of executive function (BRIEF)-Parent Form. | None. |
| Huybrechts (Controls unexposed, NOS), 2014 | cohort | The Medicaid Analytic eXtract data set that contains data on all filled outpatient medication prescriptions. | The Medicaid Analytic eXtract data set that contains data on all physician services and hospitalizations and the accompanying diagnoses and procedures. Congenital cardiac malformations were identified on the basis of International Classification of Diseases (ICD-9) codes. | None. |
| Huybrechts (Controls unexposed, NOS), 2015 | retrospective cohort (claims database) | The Medicaid Analytic eXtract (MAX) data set records health care use including filled outpatient medication prescriptions. | The Medicaid Analytic eXtract (MAX) data set records health care use including recorded diagnoses and procedures for all physician services and hospitalizations. Persistent pulmonary hypertension of the newborn was defined based on International Classification of Diseases (ICD-9) diagnostic codes. | None. |
| Huybrechts (Controls unexposed, sick), 2015 | retrospective cohort (claims database) | The Medicaid Analytic eXtract (MAX) data set records health care use including filled outpatient medication prescriptions. | The Medicaid Analytic eXtract (MAX) data set records health care use including recorded diagnoses and procedures for all physician services and hospitalizations. Persistent pulmonary hypertension of the newborn was defined based on International Classification of Diseases (ICD-9) diagnostic codes. | Adjusted for the high-dimensional propensity score: including year of delivery, age, race, multiple gestation, antidepressant indications, proxies for depression severity, other chronic maternal illness, other psychotropic medication use, antidiabetic, antihypertensive and asthma medications, and nonsteroidal anti-inflammatory drugs; and residual confounding for proxies of unmeasured confounders. |
| Huybrechts (Controls unexposed, sick), 2014 | cohort | The Medicaid Analytic eXtract data set that contains data on all filled outpatient medication prescriptions. | The Medicaid Analytic eXtract data set that contains data on all physician services and hospitalizations and the accompanying diagnoses and procedures. Congenital cardiac malformations were identified on the basis of International Classification of Diseases (ICD-9) codes. | Adjusted for the high-dimensional propensity score: including year of delivery, age, race, multiple gestation, antidepressant indications, proxies for depression severity, other chronic maternal illness, other psychotropic medication use, antidiabetic, antihypertensive and residual confounding for proxies of unmeasured confounders. |
| Isohata, 2025 | retrospective cohort | Not specified. | This study used birth registry records containing basic information, including maternal age, obstetric history, and clinical diagnoses. Delivery-related data were also reviewed, including birth weight, gestational age at delivery, Apgar scores, and neonatal complications. | Full term singletons only. No adjustment for this group of exposure. |
| Jackson, 2024 | retrospective cohort (claims database) | Medication exposure was determined by its presence or absence in the medication reconciliation document completed during hospital admission. | Clinical data were obtained from the inpatient electronic medical record system. Outcome was determined by the presence of an ICD-10 diagnosis code for postpartum hemorrhage (PPH) and a procedure code for blood transfusion. | Adjustment on induction of labor, multiple gestation, >4 previous vaginal births, prior cesarean or uterine incision, large uterine fibroids, fetal demise, polyhydramnios, placental abruption, placenta accreta, placenta previa, known coagulopathy, anemia (hematocrit <30%), and thrombocytopenia, advanced maternal age, obesity, public health insurance, and race and ethnicity group. |
| Jaeger, 2019 | retrospective cohort | Analysis of insurance records (no other details). | Analysis of insurance records (no other details). | Adjusted for maternal age, military status, multiple deliveries per mother and depression severity. |
| Jensen b, 2013 | population based cohort retrospective | The Medicinal Product Statistics which is a nationwide prescription database containing individual information on all prescriptions filled at all Danish pharmacies. | The Medical Birth Register which includes data on date of birth, gestational age, Apgar score 5 min after birth, birth weight, length of fetus, maternal smoking status during pregnancy, parity and maternal age on all deliveries in Denmark. | Adjusted for maternal age, social status, smoking status, calendar year, gender of newborn, and use of anti-epileptics, antipsychotics and other types of medication. |
| Jimenez-Solem (Controls unexposed, NOS), 2012 | population based cohort retrospective | The drug redemptions were identified using the Register of Medicinal Product Statistics which has recorded drugs dispensed from Danish pharmacies. | Congenital malformations were identified through the Danish National Hospital Register. | Multivariable logistic regressions are adjusted for mother’s age, parity, income, education, smoking and year of conception. |
| Jimenez-Solem (Controls unexposed, sick), 2012 | population based cohort retrospective | The drug redemptions were identified using the Register of Medicinal Product Statistics which has recorded drugs dispensed from Danish pharmacies. | Congenital malformations were identified through the Danish National Hospital Register. | No adjustment for this group of comparison. |
| Jordan, 2016 | retrospective cohort (registry) | Anomalies registries were linked with prescription and healthcare databases covering their source populations (Danish national Prescription and Patient register; Norway National Prescription Database; and Wales’ health and social care linked electronic databank). | Three congenital anomalies registries that contribute to EUROCAT that routinely collected data on congenital anomalies. Major congenital anomalies were classified according to the EUROCAT standard subgroups (with correspondance with ICD10). | For anomalies with >2 exposed cases in the 3 countries combined, meta-analysis of country-specific effects was undertaken, using the Mantel Haenszel method, with alternative continuity corrections. Adjusted for smoking or socio-economic status (SES). |
| Källén, 2007 | population based cohort retrospective | Drug information was obtained from routine midwife interviews at the first antenatal care center visit (in 90% before the end of week 12) using a standardized form. | Congenital malformations were identified from the Swedish Medical Birth Register, from the Register of Congenital Malformations, and from the Hospital Discharge Register. | Adjustments were made for year of birth, maternal age, parity, smoking, and previous miscarriages. |
| Källén (Controls exposed to TCA), 2004 | population based cohort retrospective | Data on first-trimester exposures are obtained by midwife interviews at the first antenatal care visit (usually week 10-12), while data on later exposures are obtained from the copies of the medical records of the antenatal care. | The Swedish Medical Birth Registry that contains data on delivery and the newborn, obtained from copies of the medical records used at delivery and at the pediatric examination of the newborn. | No adjustment for this group of comparison. |
| Källén (Controls unexposed, NOS), 2004 | population based cohort retrospective | Data on first-trimester exposures are obtained by midwife interviews at the first antenatal care visit (usually week 10-12), while data on later exposures are obtained from the copies of the medical records of the antenatal care. | The Swedish Medical Birth Registry that contains data on delivery and the newborn, obtained from copies of the medical records used at delivery and at the pediatric examination of the newborn. | Adjusted for year of birth, maternal age, parity, and maternal smoking in early pregnancy. |
| Kawai, 2023 | nested case control | All data for exposures were obtained during the first and second trimester of pregnancy. Data on children and the environment obtained using self-administered questionnaires completed by caregivers and data recorded at the time of delivery by a physician. | Data on children and the environment obtained using self-administered questionnaires completed by caregivers and data recorded at the time of delivery by a physician. | Singletons only. No adjustment for this exposure. |
| Kerr, 2018 | case control | Within 6 months of delivery, trained Birth Defects Study (BDS) nurse- interviewers contacted mothers to complete a roughly 1-hr computer-assisted telephone interview, including medications during pregnancy. | Cases and controls were ascertained at participating hospitals or birth defect registries in the same areas. | Adjusted models included maternal age, race/ethnicity, education, study center, and study year (aORs were calculated when there were five or more exposed cases). |
| Kieler, 2012 | population based cohort retrospective | The prescription registers. | From the medical birth registers and the cause of death registers, infants with persistent pulmonary hypertension of the newborn identified as an ICD-10 code P29.3 or I27.0. | Adjusted for maternal age, dispensed non-steroidal anti-inflammatory drugs and antidiabetes drugs, pre-eclampsia, chronic diseases during pregnancy, country of birth, birth year, level of delivery hospital, and birth order. |
| Kieler, 2015 | nested case control | The prescription registers include data on dispensed item, substance, brand name, and formulation, together with date of dispensing for over 95% of the total outpatient population. | In the registers the diagnoses and pregnancy complications are classified according to the national version of the International Classification of Diseases (ICD). | Controls were matched with cases by country of residence, calendar year of pregnancy end point, age, and parity. Model 2 also adjusting for use of antidiabetics, antiepileptics, or other teratogenic drugs. |
| Kildegaard, 2025 | - | |||
| Kitchin, 2022 | case control | Database for Pharmacoepidemiological Research in Primary Care, a computerized medical longitudinal population database of electronic medical records from 10.153 primary care practitioners and pediatricians distributed on nine Autonomous Regions (out of 17), which contains prescriptions. | Database for Pharmacoepidemiological Research in Primary Care, a computerized medical longitudinal population database of electronic medical records from 10.153 primary care practitioners and pediatricians, which contains medical diagnoses, medical visits, hospital admissions. | Controls individually matched to cases (maternal age, gestational age, and year of Last Menstrual Period date). Adjusted by number of GP visits, obesity, smoking, HTA, diabetes. |
| Kivistö, 2016 | retrospective cohort | The data were gathered retrospectively from the hospital birth register. | The data were gathered retrospectively from the hospital birth register. | A regression model adjusted for age, overweight, nulliparity, prior termination, miscarriages, smoking, maternal alcohol consumption, chronic illness, gestational diabetes, and polyhydramnion. |
| Klieger-Grossmann - Escitalopram, 2012 | prospective cohort | During the initial telephone contact, details of exposure and concurrent exposures were recorded using a standardized questionnaire. Details regarding the exposure included duration and timing in pregnancy, as well as dose, frequency, and indication for drug use. | After the EDD, researchers telephoned each woman to obtain the outcome of the pregnancy. Then, the researcher sent a letter to the caller’s physician if there were a live birth, asking for verification of the information obtained from the mother regarding the baby’s health. | Controls were matched for maternal age ±2 years, alcohol consumption and smoking, and gestational age at time of call ±2 weeks. |
| Knickmeyer, 2014 | retrospective cohort | Exposure during pregnancy confirmed by maternal self-report and medical record review. Self-report was in response to an oral interview. | Clinical characteristics were collected from prenatal records, labor and delivery records, and pediatric records. Children received structural MRI scans. Scans were reviewed by two independent neuroradiologists who were blind to exposure status. | Each SSRI-exposed child was matched to two comparison children using propensity scores on potential confounding variables including date of birth, gender, twin status, maternal ethnicity, maternal age, maternal education, and household income. |
| Kolding (Controls unexposed, disease free), 2021 | population based cohort retrospective | Exposure to antidepressants was measured using redeemed prescriptions through linkage to the Danish Health Services Prescription Database. | Data on prenatally diagnosed cardiac malformations came from the Danish Fetal Medicine Database and data on cardiac malformations diagnosed up to 1 year postnatally came from the Danish National Patient Registry. | Variables included in the analysis with propensity score fine stratification: ethnicity, civil status, parity, age, BMI, smoking, exposure to teratogens, antihypertensives, antidiabetics, use of other psychotropic drugs, depression diagnosis, diabetes diagnosis. |
| Kolding (Controls unexposed, sick), 2021 | population based cohort retrospective | Exposure to antidepressants was measured using redeemed prescriptions through linkage to the Danish Health Services Prescription Database. | Data on prenatally diagnosed cardiac malformations came from the Danish Fetal Medicine Database and data on cardiac malformations diagnosed up to 1 year postnatally came from the Danish National Patient Registry. | Adjusted for smoking and age at conception. |
| Kragholm, 2018 | population based cohort retrospective | Data on selective serotonin reuptake inhibitors exposure were obtained from the Danish Prescription Registry, which contains data on redeemed drug prescriptions from all Danish pharmacies. | The Danish Medical Birth Registry, information from Statistics Denmark. The outcomes 'Special education need' and 'elementary school start' were obtained from nationwide Danish education registries under Statistics Denmark. | Singleton only. Adjusted for maternal age at the time of birth, maternal educational level at the time of conception, birth year, child Apgar score, birth weight relative to gestational length/age, maternal diabetes prior to pregnancy, gestational diabetes, maternal hypertension, preeclampsia, smoking status, and preterm birth. |
| Kulin, 1998 | prospective cohort | During the initial interview at the time of exposure, women were asked notably about SSRI dose schedule and length of therapy and other drug therapy. | After the expected date of confinement, women were contacted and interviewed regarding the course of pregnancy, pregnancy outcome, and neonatal health. Reports of major malformations were corroborated with medical records. | None. |
| Laspro - Sertraline, 2024 | nested case control | Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy. | Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records. | None. |
| Latendresse, 2011 | prospective cohort | The use of medication for mental health conditions was ascertained in 2 ways. First, 1 item included in the participant questionnaire conducted during pregnancy. Second, the prenatal and birth records were reviewed for any documentation of medication use. | Prenatal and hospital birth records were reviewed to obtain information regarding prenatal course and complications; medical and obstetrical history (particularly regarding previous PTB); and to verify medication status and outcome data (preterm vs term birth) for each participant. | Controlled for age, antepartum complications, and any history of obstetric complications (including previous history of Preterm). |
| Laugesen, 2013 | population based cohort retrospective | Prescription identified through the Danish National Prescription. | ADHD was detected either as a diagnosis of ADHD or redemption of a prescription for ADHD medication. Using the Danish Psychiatric Registry and the Danish National Registry of Patients (identified with inpatient and outpatient hospital diagnoses of ADHD, with ICD codes). | Adjusted for gender of the child, calendar time at birth, birth order, maternal age at birth, maternal smoking status, maternal psychiatric diagnoses, paternal psychiatric diagnoses, maternal diseases during pregnancy (infections, epilepsy) and maternal medication (anxiolytics/ hypnotics/sedatives) use during pregnancy. |
| Lee (Controls exposed to TCAs), 2025 | retrospective cohort (claims database) | The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records. | The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including clinical information like diagnoses, clinic attendances, hospital admissions. | Singleton. No adjustment for this group of comparison. |
| Lee (Controls unexposed, general pop), 2024 | population based cohort retrospective | Maternal exposures were identified in dispensation records obtained from the Details of Ambulatory Care Orders dataset of the National Health Insurance Research Database, which includes all medication dispensations and accompanying prescriptions for all outpatient visits in Taiwan. | The Taiwan Maternal and Child Health Database which contains information on 99.78% of all births in Taiwan, enabled to obtain comprehensive information on children, their parents, maternal and paternal siblings. | Adjusted for birth order, maternal and paternal nationality, age at childbirth, and history of and severe psychiatric disorders. |
| Lee (Controls unexposed, general pop), 2025 | retrospective cohort (claims database) | The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records. | The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including clinical information like diagnoses, clinic attendances, hospital admissions. | Singleton. Adjusted for age, parity, maternal diabetes, hypertension, dyslipidaemia, epilepsy, physical comorbidity burden, gestational diabetes and hypertensive disorders, maternal psychiatric disorders, substance/alcohol use disorders, drugs during pregnancy (antipsychotics, lithium, valproate, lamotrigine, carbamazepine, benzodiazepines, z-hypnotics, opioid), history of psychiatric admission... |
| Lee (Controls unexposed, sibling), 2024 | population based cohort retrospective | Maternal exposures were identified in dispensation records obtained from the Details of Ambulatory Care Orders dataset of the National Health Insurance Research Database, which includes all medication dispensations and accompanying prescriptions for all outpatient visits in Taiwan. | The Taiwan Maternal and Child Health Database which contains information on 99.78% of all births in Taiwan, enabled to obtain comprehensive information on children, their parents, maternal and paternal siblings. | Sibling design. Adjusted for birth order, maternal and paternal nationality, age at childbirth, and history of severe psychiatric disorders. |
| Lennestal, 2007 | population based cohort retrospective | Data on maternal use of drugs were obtained through interviews performed at the first antenatal care visit (early exposure) and was supplemented with information on drugs prescribed by the antenatal care during the remaining part of the pregnancy (late exposure). | Outcomes data were obtained from delivery records, neonatal records, the Medical Birth Register, the Register of Congenital Malformations and the Hospital Discharge Register. | Adjusted for year of delivery, maternal age, parity, smoking in early pregnancy and previous miscarriage. |
| Levinson-Castiel, 2006 | retrospective cohort | The infants were identified from the delivery room records as they arrived at the nursery or from a medical history form completed by all mothers at admittance to the nursery. This form included notably type, dosage, and duration of treatment with SSRIs or other drugs. | The nurses and physicians in the center identified and recorded NAS symptoms. At discharge, the medical records were reviewed, and the Finnegan scores were assessed for possible errors. | Controls matched for sex, gestational age (±1 week), birth weight (±100 g), and mode of delivery. |
| Levy, 2020 | retrospective cohort | The electronic files of women were reviewed. | Data regarding pregnancy outcome was obtained from the electronic files. | The control group was matched in a 1:1 ratio with unexposed pregnancies by year, mode of delivery, gestational-age, and maternal age. Multivariable regression analyses were performed to identify independent associations (NOS). |
| Liu, 2017 | population based cohort retrospective | Information on antidepressant use came from the Danish National Prescription Registry, that covers all prescriptions dispensed in Denmark since 1995. | Information on psychiatric diagnosis came from the Danish Psychiatric Central Research Register, that holds information on all inpatient and outpatient psychiatric treatment in Denmark. Primary outcome was first diagnosis of psychiatric disorders (ICD-10 codes F00-F99) in the offspring. | Adjusted for maternal age, primiparity, maternal psychiatric history, inpatient and outpatient psychiatric treatment from 2 years before pregnancy, dispensing of other psychotropic or antiepileptic during pregnancy, nb of non-psychiatric hospital visits during pregnancy, smoking, place of residence, marital status, highest education, income, year of delivery, and paternal psychiatric history. |
| Liu, 2015 | population based cohort retrospective | Data on maternal or paternal antidepressants dispensed 1 year before or during the index pregnancy and dispensing date were extracted from the Danish National Prescription Registry. | Asthma in children was identified by using the Danish National Patient Register and the Danish National Prescription Registry. Asthma was defined as at least 2 prescriptions for antiasthmatic medications or 1 asthma hospital contact (based on ICD- 10 codes J45 and J46) after 3 years of age. | Adjusted for maternal country of origin, maternal age at delivery, maternal parity, maternal social status, maternal smoking during pregnancy, maternal history of asthma, gender of the child, and calendar year of birth. |
| Louik, 2007 | case control | Detailed data are collected on all medications (prescription, over-the-counter, vitamins and minerals, and herbal products) used at any time from 2 months before conception through the end of the pregnancy, by mother completion of a 45-to-60-minute interview within 6 months after delivery. | Research staff identify subjects by reviewing clinical and surgical logs, reviewing admission and discharge lists, and contacting newborn nurseries and labor and delivery rooms. Nonmalformed infants were identified in a population-based random sample of newborns in Massachusetts. | Adjusted for maternal age, maternal race or ethnic group, maternal education, year of last menstrual period/study center, parity, first-trimester smoking status, first-trimester alcohol consumption, any family history of a birth defect, history of a cardiac defect in a first-degree relative, prepregnancy body-mass index, seizures, diabetes mellitus, hypertension, infertility, use of folic acid. |
| Louik, 2014 | case control | Mothers are invited to participate in a telephone interview after delivery, conducted by trained nurses who are unaware of the study hypotheses. It collects detailed data on all medications (prescription, over-the-counter, ...) used anytime from 2 months prior to conception through the pregnancy. | Research staff identify malformed subjects by reviewing hospital admission and discharge lists or from statewide birth-defect registries and mothers of non-malformed infants were identified at study hospitals and from a population-based random sample of newborns in Massachusetts. | Controls matched to cases on age within 2 months. Adjusted for study center, family history of birth defect and/or last menstrual period (LMP). |
| Lund (Controls unexposed, disease free), 2009 | prospective cohort | During the early second trimester, women were asked to complete a self-administered questionnaire, including information on medical treatment during pregnancy. Exposure also reported in the coding sheet filled in by the midwife at delivery. | The attending midwife completes a structured coding sheet with information about the course of delivery, pregnancy complications, and newborn characteristics (weight, length, gestational age, head circumference, Apgar score, and immediate admission to the neonatal intensive care unit [NICU]). | Preterm: adjusted for maternal age, body mass index, smoking, a previous pregnancy with prematurity, and parity. LBW: adjusted for maternal age, body mass index, smoking, parity, gestational age, previous birth of a low-birth-weight infant, and marital status. Neonates care: adjusted for maternal age, body mass index, smoking, gestational age, and parity. |
| Lund (Controls unexposed, sick), 2009 | prospective cohort | During the early second trimester, women were asked to complete a self-administered questionnaire, including information on medical treatment during pregnancy. Exposure also reported in the coding sheet filled in by the midwife at delivery. | The attending midwife completes a structured coding sheet with information about the course of delivery, pregnancy complications, and newborn characteristics (weight, length, gestational age, head circumference, Apgar score, and immediate admission to the neonatal intensive care unit [NICU]). | No adjustment for this group of comparison. |
| Lupattelli (Controls exposed to TCA), 2017 | prospective cohort | Data about antidepressant exposure were gathered prospectively from 2 self‐completed questionnaires at Gestational weeks 17 (Q1) and 30 (Q3). Women reported the name of the medication taken along with timing of use (6 months before pregnancy and during pregnancy by 4‐week intervals). | Outcomes as registered in the Medical Birth Registry of Norway (MBRN). | Adjusted for maternal age, body mass index at conception, womans socioeconomic status, educational level, parity, smoking status in pregnancy, weight gain, comedication with analgesics or other psychotropics, lifetime history of major depression, and average z‐score of depressive and anxiety symptoms at 2 time points in pregnancy. |
| Lupattelli (Controls unexposed, disease free), 2014 | prospective cohort | Information about type and timing of antidepressant use was retrieved from pregnant women self-administered questionnaires (Q1, Q3, and Q4) completed during and after pregnancy | The outcome postpartum hemorrhage stems from the Medical Birth Registry of Norway (MBRN) records, and is medically confirmed information. Information on bleeding outcomes during pregnancy was retrieved from self-administered questionnaires (Q1, Q3). | Bleeding adjusted for maternal age, parity, BMI, educational level, NSAID and antithrombotic use, smoking, previous abortions and/or miscarriages, and depressive symptoms. PP hemorrhage adjusted for maternal age, parity, BMI, educational level, smoking, coagulation defects, history of previous abortion/miscarriage, placental abruption, placenta previa, and maternal depressive symptoms. |
| Lupattelli (Controls unexposed, sick), 2017 | prospective cohort | Data about antidepressant exposure were gathered prospectively from 2 self‐completed questionnaires at Gestational weeks 17 (Q1) and 30 (Q3). Women reported the name of the medication taken along with timing of use (6 months before pregnancy and during pregnancy by 4‐week intervals). | Outcomes as registered in the Medical Birth Registry of Norway (MBRN). | Adjusted for maternal age, body mass index at conception, woman0s socioeconomic status, educational level, parity, smoking status in pregnancy, weight gain, comedication with analgesics or other psychotropics, lifetime history of major depression, and average z‐score of depressive and anxiety symptoms at 2 time points in pregnancy. |
| Lupattelli (Controls unexposed, sick), 2014 | prospective cohort | Information about type and timing of antidepressant use was retrieved from pregnant women self-administered questionnaires (Q1, Q3, and Q4) completed during and after pregnancy | The outcome postpartum hemorrhage stems from the Medical Birth Registry of Norway (MBRN) records, and is medically confirmed information. Information on bleeding outcomes during pregnancy was retrieved from self-administered questionnaires (Q1, Q3). | No adjustment for this group of comparison. |
| Lyn, 2023 | retrospective cohort | Not specified. | Not specified. | No adjustment (result after controlling for age, birthweight, gestation and mode of delivery not provided). Control group matched by completed weeks of gestation and mode of delivery. Fetal anomalies, stillbirths and multiple gestations were excluded. |
| Malm, 2011 | population based cohort retrospective | The Drug Reimbursement Register that contains data on 98% of reimbursed prescription drug purchases. | The Medical Birth Register and the The Register of Congenital Malformations, which data on diagnoses during pregnancy and delivery and neonatal outcome data (including major malformations). Data are collected from all maternity hospitals and include all births and stillbirths. | Independent variables considered in the adjusted logistic model were maternal age at the end of pregnancy, parity, year of pregnancy ending, marital status, smoking during pregnancy, purchase of other reimbursed psychiatric drugs (including antiepileptics) during the first trimester, and maternal prepregnancy diabetes. |
| Malm (Controls unexposed, disease free), 2015 | population based cohort retrospective | The Drug Reimbursement Register which collect data on prescription drug purchases. Over- the-counter drugs and medications administered to institutionalized persons are not included. | The Medical Birth Register which collect data on maternal diagnoses during pregnancy and delivery, and neonatal outcome using ICD codes. Data are collected in a standard form from all maternity hospitals and are virtually complete after data linkages to other governmental register resources. | Adjusted odds ratios were adjusted for sex, birth period, maternal age at delivery, place of residence, marital status, parity, smoking, socioeconomic status, purchase of anxiolytics, sedative-hypnotics, or antiepileptic drugs, prepregnancy diabetes, and other chronic diseases. |
| Malm (Controls unexposed, disease free), 2016 | population based cohort retrospective | The Drug Reimbursement Register that collects data on prescription drug purchases and was used to identify the study groups. | The Hospital Discharge Register (HDR) includes inpatient diagnoses covering all somatic and psychiatric hospitals in Finland. Information on parental psychiatric diagnoses (ICD-8, ICD-9 and ICD-10), and diagnoses of neuropsychiatric disorders in offspring (ICD-10) were derived from this register. | Adjusted for sex, socioeconomic status, maternal history of other psychiatric diagnosis, and for depression: smoking, drug abuse, paternal psychiatric diagnosis; for Anxiety: marital status, smoking, antiepileptics, preterm, birth weight, parental death; for ASD: age, chronic disease, preterm, neonatal care unit; for ADHD: smoking, NCU, drug abuse, paternal psychiatric diagnosis, parental death |
| Malm (Controls unexposed, sick), 2015 | population based cohort retrospective | The Drug Reimbursement Register which collect data on prescription drug purchases. Over- the-counter drugs and medications administered to institutionalized persons are not included. | The Medical Birth Register which collect data on maternal diagnoses during pregnancy and delivery, and neonatal outcome using ICD codes. Data are collected in a standard form from all maternity hospitals and are virtually complete after data linkages to other governmental register resources. | Adjusted odds ratios were adjusted for sex, birth period, maternal age at delivery, place of residence, marital status, parity, smoking, socioeconomic status, purchase of anxiolytics, sedative-hypnotics, or antiepileptic drugs, prepregnancy diabetes, and other chronic diseases. |
| Malm (Controls unexposed, sick), 2016 | population based cohort retrospective | The Drug Reimbursement Register that collects data on prescription drug purchases and was used to identify the study groups. | The Hospital Discharge Register (HDR) includes inpatient diagnoses covering all somatic and psychiatric hospitals in Finland. Information on parental psychiatric diagnoses (ICD-8, ICD-9 and ICD-10), and diagnoses of neuropsychiatric disorders in offspring (ICD-10) were derived from this register. | Adjusted for sex, socioeconomic status, maternal history of other psychiatric diagnosis, and for depression: smoking, drug abuse, paternal psychiatric diagnosis; for Anxiety: marital status, smoking, antiepileptics, preterm, birth weight, parental death; for ASD: age, chronic disease, preterm, neonatal care unit; for ADHD: smoking, NCU, drug abuse, paternal psychiatric diagnosis, parental death |
| Man, 2015 | case control | Electronic medical records on the Clinical Data Analysis and Reporting System. | Electronic medical records on the Clinical Data Analysis and Reporting System. | Adjusted (NOS). |
| Man (Controls exposed to antipsychotics), 2017 | retrospective cohort (claims database) | Antidepressant use in mothers was extracted from the prescribing and dispensing records in the Clinical Data Analysis and Reporting System (CDARS). | The Clinical Data Analysis and Reporting System (CDARS) that contains diagnosis, laboratory test results, and admission and discharge information, with ADHD registered as ICD-9-CM diagnosis code 314, or a prescription for an ADHD drug. | Adjusted for maternal age at delivery, infant’s sex, birth year, birth hospital, parity, maternal underlying illness before delivery (pre-existing diabetes, epilepsy, gestational diabetes, hypertension), socioeconomic status, maternal psychiatric conditions, and other psychiatric drug use. |
| Man (Controls unexposed, NOS), 2017 | retrospective cohort (claims database) | Antidepressant use in mothers was extracted from the prescribing and dispensing records in the Clinical Data Analysis and Reporting System (CDARS). | The Clinical Data Analysis and Reporting System (CDARS) that contains diagnosis, laboratory test results, and admission and discharge information, with ADHD registered as ICD-9-CM diagnosis code 314, or a prescription for an ADHD drug. | Adjusted for maternal age at delivery, infant’s sex, birth year, birth hospital, parity, maternal underlying illness before delivery (pre-existing diabetes, epilepsy, gestational diabetes, hypertension), socioeconomic status, maternal psychiatric conditions, and other psychiatric drug use. |
| Manakova, 2011 | prospective cohort | The details of exposure were obtained after enrollment in the study. The data collection at the first contact and follow up were obtained by phone call or by written e-mail questionnaire. | The data collection at the first contact and follow up were obtained by phone call or by written e-mail questionnaire. Risk of malformations in general population was estimated according to data published by ÚZIS for relevant years. | None. |
| Margulis, 2013 | retrospective cohort (claims database) | The Clinical Practice Research Datalink (CPRD), formerly called GPRD, an automated health care database that contains prescriptions. Prescriptions with fields for the patient and product identifiers, and dose are issued electronically. | The Clinical Practice Research Datalink (CPRD), formerly called GPRD, an automated health care database that contains medical records. | Main analysis: propensity score matching using unconditional logistic regression with no additional co-variates. Matching selected a priori: year, age, marital status, family history of congenital malformations, body mass, diabetes, cigarette smoking, alcohol in- take, diagnosis of depression in baseline year, diagnosis of other mental conditions, number of health care encounters in baseline year. |
| Marks - Sertraline (Controls exposed to Bupropion), 2021 | retrospective cohort | Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis. | Diagnoses were extracted from the electronic database discharge summaries, delivery records, and/or International Classification of Diseases (ICD) codes. Clinical diagnosis were extracted from the delivery discharge summary written by the clinician caring for the infant. | All results reported as aOR (95% CI) controlling for maternal race, age, insurance, and gestational age at delivery. |
| Marks - Sertraline (Controls unexposed, sick), 2021 | retrospective cohort | Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis. | Diagnoses were extracted from the electronic database discharge summaries, delivery records, and/or International Classification of Diseases (ICD) codes. Clinical diagnosis were extracted from the delivery discharge summary written by the clinician caring for the infant. | All results reported as aOR (95% CI) controlling for maternal race, age, insurance, and gestational age at delivery. |
| Martin - Sertraline, 2024 | population based cohort retrospective | In the UK, prescription data were based on the prescriptions written by general practitioners (CPRD GOLD), whereas in Norway and Sweden, dispensation of prescription drugs from all ambulatory pharmacies was used (Norwegian Prescription Database, and Swedish Prescribed Drug Register). | The UK Clinical Practice Research Datalink that contains diagnoses made in primary care and secondary care data; Norway: Medical Birth Registry of Norway and the Norwegian Patient Registry; and Sweden: the Medical Birth Register of Sweden and the National Patient Register. | Singletons only. Adjusted for maternal age at delivery, early-pregnancy body mass index, parity, previous stillbirth, anti-seizure medication and antipsychotic use in the 12 months prior to pregnancy, smoking anytime during pregnancy, maternal depression or anxiety diagnosis prior to the start of pregnancy, proxy measures of socioeconomic position (SEP). |
| Maschi - Fluoxetine, 2008 | prospective cohort | Maternal demographic data, indication for treatment and time of exposure were collected using a structured questionnaire. | A follow-up interview was performed to collect information concerning pregnancy outcome, details of labour and delivery and neonatal complications, including Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) admissions. | Controls matched for maternal age and gravidity. |
| Maschi - Paroxetine, 2008 | prospective cohort | Maternal demographic data, indication for treatment and time of exposure were collected using a structured questionnaire. | A follow-up interview was performed to collect information concerning pregnancy outcome, details of labour and delivery and neonatal complications, including Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) admissions. | Controls matched for maternal age and gravidity. |
| Merlob, 2009 | prospective cohort | A standardized pregnancy questionnaire is administered to all women on admittance to the maternity ward and reviewed by the attending neonatologist. The use of any drug during pregnancy is routinely recorded. | Every infant born at the center during that period was examined on the first day of life for cardiac murmur. Those with a persistent murmur on the second or third day of life were examined by a pediatric cardiologist and referred for electrocardiography and echocardiography. | None. |
| Misri, 2006 | prospective cohort | Recruitment for the subject/depressed groups was done during pregnancy, while recruitment for the control group began after delivery. | Three methods were used: as reported by parents (the Child Behavior Checklist), caregivers (Child-Teacher Report Forms), and as objectively coded from mother and child interactions by a clinician. | No adjustment for this group of exposure (SSRI) versus this group of comparison (Control). |
| Morimoto, 2021 | retrospective cohort | Medication records were investigated to confirm the use of antipsychotics, selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, anticonvulsants, and nonbenzodiazepine hypnotics. | Medical records (Neonatal abstinence syndrome (NAS) was diagnosed using the Isobe score, a modified Finnegan score widely used in Japan). | Multivariate analysis incorporating antipsychotic usage, benzodiazepine usage, nonbenzodiazepine hypnotic drug usage, antiepileptic usage, smoking, alcohol and multiple medications into the model. |
| Mulder, 2011 | prospective cohort | A longitudinal design with three times of assessment aimed to collect data for the mother and her fetus at 15–19 wGA at time 1 (T1), 27–29 wGA at time 2 (T2), and 37–39 wGA at time 3 (T3). A questionnaire booklet was mailed to the participant about 1 week before each appointment. | A questionnaire booklet was mailed to the participant about 1 week before each appointment. The principal investigator (EJHM) remained blind to the mental health and drug status of the women until all fetal data had been collected and analyzed. | None |
| Nakhai-Pour, 2010 | nested case control | The Régie de l’assurance maladie du Québec (RAMQ) database which provides prospectively collected data on filled prescriptions. | The Régie de l’assurance maladie du Québec (RAMQ) (physician-based diagnoses according to the ICD-9), the Med-Echo database (data on acute care hospital admissions) and the Institut de la statistique du Québec database (data on all births and deaths in Quebec). | Match. Adjusted for maternal age, social assistance status and place of residence; gestational age at index date; comorbidities (diabetes mellitus, cardiac disease, asthma, untreated thyroid disease, depression, anxiety, bipolar disorder); history of abortions; visits to physicians; duration of antidepressants; prenatal visits and other medication use in the year before and during pregnancy. |
| Neo, 2020 | case control | To determine whether infants were prenatally exposed to SSRIs, two investigators (DTN and EN) independently reviewed each maternal chart, blinded as to whether the infants received therapeutic hypothermia. | Cases were identified from the electronic medical record. Controls were the next four noncase deliveries within 6 months of the case. | Controls matched to cases by obstetric provider group, hospital shift, completed weeks of gestation, and maternal age ± 3 years. Adjusted for race/ ethnicity. |
| Nielsen, 2017 | population based cohort retrospective | The Nationwide Prescription Database, for all reimbursed drug prescriptions issued from Danish pharmacies. | The Danish National Patient Registry (NPR, that includes records of all discharges from Danish hospitals and since 1994 all out-patient visits) and the Danish Medical Birth Registry (MBR, with information on all births). Classification diagnosis of Hirschsprung’s disease (ICD-10: DQ431). | Adjustment was made for maternal age, maternal smoking status, parity, sex of the child, and calendar year of birth. |
| Nijenhuis (Controls exposed to TCA), 2012 | retrospective cohort (claims database) | The pharmacy prescription database IADB.nl which contains pharmacy prescription data of an estimated population of 500 000 individuals from the Netherlands. | The use of laxatives (ATC code = A06) and antidiarrhoeal medication (ATC code = A07C; A07D; A07F; A07X) in the newborn, regarded as a proxy for constipation and diarrhoea, respectively. | None. |
| Nijenhuis (Controls unexposed, NOS), 2012 | retrospective cohort (claims database) | The pharmacy prescription database IADB.nl which contains pharmacy prescription data of an estimated population of 500 000 individuals from the Netherlands. | The use of laxatives (ATC code = A06) and antidiarrhoeal medication (ATC code = A07C; A07D; A07F; A07X) in the newborn, regarded as a proxy for constipation and diarrhoea, respectively. | None. |
| Nishigori, 2017 | population based cohort retrospective | The researchers gathered information on drug use both before and after pregnancy using two interviews in the first gestational trimester then the 2nd or 3rd gestational trimester. For these two questionnaires, the research coordinators collected the information using direct interviews. | Two questionnaires were designed to gather data on the outcome of the pregnancy and the offspring. This included information regarding major congenital anomalies identified in the baby and described by perinatal doctors | Adjusted for age, marital status, body mass index (kg/m2), smoking and drinking habits, smoking habits of partner, infertility treatments, in vitro fertilization, diabetes or gestational diabetes, hypertension, anti-depressant drug except the SSRI, other psychiatric drugs, hypoglycemic tablet, anti-hypertensive drug and folic acid. |
| Norby, 2016 | population based cohort retrospective | At their initial visit, in 90% of the cases in the 1st trimester, the women are interviewed by their midwife, medication data are prospectively collected and registered in the Medical Birth Register (MBR). Data on medications were acquired from this way (MBR) and the PDR (Prescribed Drug Register). | Data on admissions to neonatal wards were extracted from the national Swedish Neonatal Quality Register (SNQ). Infants diagnoses also recorded from the SNQ via checkboxes in the infant’s medical record and from the Medical Birth Register (MBR). | Adjusted for Maternal age, year of birth, primiparity, maternal smoking, BMI, mother born in Sweden, cohabiting with the child’s father, cesarean delivery, and any use of mild sedatives during pregnancy; and gestational age and fetal weight for GA and sex (birth weight z scores). |
| Nordeng (Controls unexposed, NOS), 2012 | cohort | The pregnant women completed 2 questionnaires during pregnancy at around gestational weeks 17 and 30, which included notably questions regarding medication use. | The Medical Birth Registry of Norway (MBRN) which contains detailed medical information and diagnostics regarding the infant originating from mandatory notification forms completed by midwives, obstetricians, and/or pediatricians at delivery and during the hospital stay. | Malfo: adjusted for maternal depression, maternal age at delivery, parity, and use of psychotropic drugs during pregnancy. Preterm, LBW: adjusted for level of depression, maternal age at delivery, education, parity, prepregnancy BMI, maternal asthma or cardiovascular disease, NSAID use, folic acid use, and smoking during pregnancy. |
| Nordeng (Controls unexposed, sick), 2012 | cohort | The pregnant women completed 2 questionnaires during pregnancy at around gestational weeks 17 and 30, which included notably questions regarding medication use. | The Medical Birth Registry of Norway (MBRN) which contains detailed medical information and diagnostics regarding the infant originating from mandatory notification forms completed by midwives, obstetricians, and/or pediatricians at delivery and during the hospital stay. | No adjustment for this group of comparison. |
| Nulman (Controls unexposed, disease free), 2012 | prospective cohort | At the time of the first contact with Motherisk during pregnancy, information about medications was collected. | A psychometrist masked to group affiliation tested all children individually using a battery of age-appropriate standardized psychological tests. | None |
| Nulman (Controls unexposed, sick), 2012 | prospective cohort | At the time of the first contact with Motherisk during pregnancy, information about medications was collected. | A psychometrist masked to group affiliation tested all children individually using a battery of age-appropriate standardized psychological tests. | None. Exclusion of mothers exposed to polytherapy for depression or known teratogens (e.g., antiepileptic drugs), with substance abuse (e.g., alcohol use disorders), with otherpsychiatric conditions (e.g., schizophrenia), premature children (below 37 weeks of gestation), mothers and/or children with medical conditions that may affect cognitive outcomes (e.g., postnatal head trauma, encephalitis). |
| Nulman - Fluoxetine (Controls exposed to TCA), 1997 | prospective cohort | During the initial assessment, at the diagnosis of pregnancy or within several weeks thereafter, the Service obtained a medical history of each woman, including use of medicinal drugs. Information concerning the time of drug therapy was recorded, as were the doses and of any concomitantly drugs. | All children were assessed by a psychometrician who did not know the nature of the intrauterine exposure. | None |
| Nulman - Fluoxetine (Controls exposed to TCA), 2002 | prospective cohort | During the initial consultation, during early pregnancy, Details concerning the time and duration of exposure to the antidepressant drugs, and the doses of any other concomitant medications were recorded was obtained from each mother. | The children were assessed by a psychometrist blinded to the exposure with the Bayley Scales of Infant Development-II or the McCarthy Scales of Children’s Abilities, the Toddler Temperament Scale or the Achenbach Child Behavior Checklist and the Reynell Developmental Language Scales. | None |
| Nulman - Fluoxetine (Controls unexposed, disease free), 2002 | prospective cohort | During the initial consultation, during early pregnancy, Details concerning the time and duration of exposure to the antidepressant drugs, and the doses of any other concomitant medications were recorded was obtained from each mother. | The children were assessed by a psychometrist blinded to the exposure with the Bayley Scales of Infant Development-II or the McCarthy Scales of Children’s Abilities, the Toddler Temperament Scale or the Achenbach Child Behavior Checklist and the Reynell Developmental Language Scales. | None |
| Nulman - Fluoxetine (Controls unexposed, NOS), 1997 | prospective cohort | During the initial assessment, at the diagnosis of pregnancy or within several weeks thereafter, the Service obtained a medical history of each woman, including use of medicinal drugs. Information concerning the time of drug therapy was recorded, as were the doses and of any concomitantly drugs. | All children were assessed by a psychometrician who did not know the nature of the intrauterine exposure. | None |
| Oberlander, 2004 | prospective cohort | Measure of plasma level of maternal Selective serotonin reuptake inhibitor medications. | Concern about respiratory or other symptoms on the part of the family physician, midwife or obstetrician led to assessment by the pediatrician. Physicians who had been asked to assess distressed newborns were partially blinded to the infants' prenatal exposure status. Physician reviewed chart. | None. |
| Oberlander, 2007 | prospective cohort | Recruitment for the subject/depressed groups was done during pregnancy, while recruitment for the control group began after delivery (during the newborn period). | Administration of the Child Behavior Check-list (CBCL) and Child-Teacher Report Form completed by the child’s mother and teacher, respectively, with examination of some specific subscales. A blind assessment of each child’s activity was obtained from observations of caregiver-child interactions. | None. |
| Oberlander a, 2008 | retrospective cohort (claims database) | PharmaNet, a province-wide network recording all prescriptions dispensed by British Columbian pharmacists outside hospitals. | Five administrative sources housed in the BC Linked Health Database: British Columbia registry of births, hospital separation records, the PharmaCare registry of subsidized prescriptions; the Medical Services Plan physician billing records; and the registry of Medical Services Plan subscribers. | None (adjustment provided for risk difference but not for relative risk or odd ratio). |
| Ogawa, 2018 | nested case control | For each person, the Japan Medical Data Center (JMDC) database includes prescriptions. The classification of drugs is based on the Anatomical Therapeutic Chemical classification system of the European Pharmaceutical Market Research Association. | For each person, the Japan Medical Data Center (JMDC) database includes an encrypted personal identifier, age, gender and diagnoses. | Inclusion of first singleton pregnancy. Women with alcohol or nicotine dependence were excluded. Adjusted for maternal age, preeclampsia, chorioamnionitis, diabetes, hypertension, systemic lupus erythematosus, asthma, hyperthyroidism and hypothyroidism. |
| Olstad - (Es)citalopram (Controls unexposed, disease free), 2023 | population based cohort propective | Information about the maternal use of (es)citalopram was retrieved from the questionnaires Q1, Q3, and Q4 for 4-week intervals (gestational weeks 0–4; 5–8; 9–12; 13–16; 17–20; 21–24; 25–28; 30–birth). | Child neurodevelopment was assessed using parental self-reports on internationally recognized psychometric tests (the Child Behavior Checklist (CBCL) and the Ages and Stages Questionnaire). Diagnoses of ADHD retrieved from the Norwegian Patient Registry (NPR) recorded by specialists (ICD-10: F90). | Propensity score matching for maternal income, body mass index, lifetime history of major depression (but significant difference (SD)), smoking (but SD) and alcohol at the start of pregnancy, and parity. Singletons only. Exclusion of women using antiepileptics and psycholeptics. Non different variables: infant sex, chronic diseases and prenatal exposure to non-steroidal anti-inflammatory drugs. |
| Olstad - (Es)citalopram (Controls unexposed, sick), 2023 | population based cohort propective | Information about the maternal use of (es)citalopram was retrieved from the questionnaires Q1, Q3, and Q4 for 4-week intervals (gestational weeks 0–4; 5–8; 9–12; 13–16; 17–20; 21–24; 25–28; 30–birth). | Child neurodevelopment was assessed using parental self-reports on internationally recognized psychometric tests (the Child Behavior Checklist (CBCL) and the Ages and Stages Questionnaire). Diagnoses of ADHD retrieved from the Norwegian Patient Registry (NPR) recorded by specialists (ICD-10: F90). | No adjustment/matching for this group of comparison. Singletons only. Exclusion of women using antiepileptics and psycholeptics. No difference between the 2 groups for: body mass index, chronic diseases, smoking, alcohol, analgesics use, infant sex, birth weight and gestational age. |
| Ozturk - Escitalopram, 2016 | prospective cohort | At the first contact, initiated via gynecologists, a detailed patient history form was used to notably record all drug exposures (dose, duration and timing in pregnancy). | Each newborn baby was checked at birth for signs of problems or complications. | None |
| Palmsten, 2020 | retrospective cohort (claims database) | Antidepressant pharmacy dispensing information from 3 months before the LMP through 35 gestational weeks. | International Classification of Disease (ICD) 9 or 10 diagnosis or procedure codes and Current Procedural Terminology (CPT) procedure codes used to define deliveries and outcomes. | No adjustment for this group of exposure (addition of trajectories B, D and E). |
| Palmsten (control exposed to TCA), 2013 | retrospective cohort (claims database) | Outpatient pharmacy-dispensing data. | Medicaid enrollment information was linked to inpatient and outpatient procedures and diagnoses. Outcome validity was assessed by reviewing delivery hospital medical records for a sample of 183 women. Preeclampsia defined with ICD-9 code for preeclampsia or eclampsia (642.4x–642.7x). | Adjusted for delivery year, preeclampsia risk factors (age, race/ethnicity, primiparity, diabetes, multifetal gestation, pain-related diagnosis...), depression severity proxies, other antidepressant indications, other medications, and healthcare utilization. |
| Palmsten (Controls exposed to TCA), 2012 | retrospective cohort (claims database) | PharmaNet database, which contains all non-hospital pharmacy dispensings. | Province-wide health-care utilization databases which contain diagnostic and procedural information from all physician services and hospitalizations. | Adjusted for delivery year, age, diabetes, multifetal gestation, obesity, primiparity, and physician visits, number of depression claims, number of psychiatrist visits/mental health hospitalizations, and dispensing of benzodiazepines, anticonvulsants, and antipsychotics. |
| Palmsten (Controls unexposed, sick), 2013 | retrospective cohort (claims database) | Outpatient pharmacy-dispensing data. | Medicaid enrollment information was linked to inpatient and outpatient procedures and diagnoses. Outcome validity was assessed by reviewing delivery hospital medical records for a sample of 183 women. Preeclampsia defined with ICD-9 code for preeclampsia or eclampsia (642.4x–642.7x). | Adjusted for delivery year, preeclampsia risk factors, depression severity proxies, other antidepressant indications, other medications, and healthcare utilization. |
| Palmsten (Controls unexposed, sick), 2012 | retrospective cohort (claims database) | PharmaNet database, which contains all non-hospital pharmacy dispensings. | Province-wide health-care utilization databases which contain diagnostic and procedural information from all physician services and hospitalizations. | Adjusted for delivery year, age, diabetes, multifetal gestation, obesity, primiparity, and physician visits, number of depression claims, number of psychiatrist visits/mental health hospitalizations, and dispensing of benzodiazepines, anticonvulsants, and antipsychotics. |
| Palmsten b, 2013 | retrospective cohort (claims database) | Data of prescription. | Women with an ICD-9 code for 666.x during the admission to hospital for delivery, or within three days after the delivery date, were classified as having postpartum hemorrhage. Atonic postpartum hemorrhage only (666.1x) and inpatient postpartum hemorrhage only, also considered. | Adjusted for delivery year, age, race, multiple pregnancy, diabetes, coagulopathy, number of outpatient and inpatient mood/anxiety disorder diagnoses, other mental health disorder, pain indication, sleep disorder, anticonvulsant, benzodiazepine, aspirin, heparin, low molecular weight heparin and warfarin dispensing, and number of outpatient visits and days in hospital during baseline. |
| Pastuszak - Fluoxetine (Controls exposed to TCA), 1993 | prospective cohort | Drug exposure history was obtained from both the mother and biological father of the fetus, by an interview with a team physician. | All patients were contacted by telephone and asked details about the outcome of pregnancy, birth weight, and presence or absence of birth defects, and perinatal complications. All follow-up information was corroborated by written documentation from the child's physician. | Control group was age-matched (±2 years) to two controls, closest in date to the date of consultation of the fluoxetine case. |
| Pastuszak - Fluoxetine (Controls unexposed, NOS), 1993 | prospective cohort | Drug exposure history was obtained from both the mother and biological father of the fetus, by an interview with a team physician. | All patients were contacted by telephone and asked details about the outcome of pregnancy, birth weight, and presence or absence of birth defects, and perinatal complications. All follow-up information was corroborated by written documentation from the child's physician. | Control group was age-matched (±2 years) to two controls, closest in date to the date of consultation of the fluoxetine case. |
| Pearson (Controls exposed to TCA), 2007 | retrospective cohort | Review of obstetrical and neonatal records. | Medical records were evaluated by 2 psychiatrists (K.H.P., M.B.) and an obstetrician (V.L.H.) blinded to the mother’s medication status in order to rate specific neonatal outcome measures. | No match/adjustment for this group of exposure. |
| Pearson (Controls unexposed, NOS), 2007 | retrospective cohort | Review of obstetrical and neonatal records. | Medical records were evaluated by 2 psychiatrists (K.H.P., M.B.) and an obstetrician (V.L.H.) blinded to the mother’s medication status in order to rate specific neonatal outcome measures. | No match/adjustment for this group of exposure. |
| Pedersen, 2010 | population based cohort retrospective | Information on medication use in early pregnancy was obtained partly through a self- administered questionnaire linked to the consent form. After consent was obtained, the women were contacted twice during pregnancy. | Information on developmental achievements in early childhood was collected mainly through computer-assisted telephone interviews with the mothers. Developmental milestones were reported by the mothers in the 2 postnatal interviews. | ORs were adjusted for maternal age, gender, age at interview, breastfeeding, problems during pregnancy, mother-child connection, and postnatal symptoms of depression. |
| Rai (Controls exposed to TCA), 2017 | prospective cohort | Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005). | Diagnostic information of autism were collected the national patient register, the Stockholm child and adolescent mental health register, and the habilitation registers (ICD-9 (299), ICD-10 (F84), or DSM-IV (299) codes). | No adjustment for this group of comparison. |
| Rai (Controls unexposed, disease free), 2017 | prospective cohort | Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005). | Diagnostic information of autism were collected the national patient register, the Stockholm child and adolescent mental health register, and the habilitation registers (ICD-9 (299), ICD-10 (F84), or DSM-IV (299) codes). | No adjustment for this group of comparison. |
| Rai (Controls unexposed, sick), 2017 | prospective cohort | Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005). | Diagnostic information of autism were collected the national patient register, the Stockholm child and adolescent mental health register, and the habilitation registers (ICD-9 (299), ICD-10 (F84), or DSM-IV (299) codes). | Models are adjusted for birth year, maternal depression, and antidepressant polypharmacy (binary variable for use of 2 or more antidepressants). |
| Rampono, 2009 | prospective cohort | The antidepressant and dose for each individual patient was determined by the prescriber (JR) according to the patients needs. The analyses of medicines and metabolites in maternal and infant plasma were carried out by high performance liquid chromatography. | Infant behaviour in relation to medication intolerance/ withdrawal was assessed daily by the midwives while the infants were in the postnatal wards using the Finnegan neonatal abstinence scoring system (NAS). The assessors were blinded to the treatment or control group classification. | None. |
| Raviv, 2025 | retrospective cohort | The mother’s information retrieved from the maternity hospital database included the reported Selective serotonin reuptake inhibitor treatment during the current pregnancy. | The variables of interest were retrieved from electronic medical files (of the mother and newborn) contains both self-reported patient information, measured parameters, laboratory results, and physician’s notes on diagnoses, management, and surveillance. | No adjustment. Infants born at term. Only infants born to mothers without documented thyroid disease and/or chronic medication administration, except for Selective serotonin reuptake inhibitors were included. |
| Reebye, 2002 | prospective cohort | Recruitment for the subject/depressed groups was done during pregnancy, while recruitment for the control group began on day 1 postpartum. | Infants were assessed at age two months on the Bayley Scales of Infant Development, 2nd edition and the mother completed the Early Infancy Temperament Questionnaire. Mother–infant interaction sequences were scored using the Parent Child Early Relational Assessment scale (PCERA). | None. |
| Reis (Controls exposed to TCA), 2010 | population based cohort retrospective | Information on drug use is partly based on an interview conducted by the midwife at the first antenatal visit (in 90% of cases before the end of the first trimester) and partly on information from the antenatal care with respect to drugs prescribed later during the pregnancy by the attending doctor. | The Swedish Medical Birth Register, the Register of Birth Defects (previously known as the Register of Congenital Malformations) and the Patient Register (previous the Hospital Discharge Register). | Singletons only. No adjustment for this group of comparison. |
| Reis (Controls unexposed, NOS), 2010 | population based cohort retrospective | Information on drug use is partly based on an interview conducted by the midwife at the first antenatal visit (in 90% of cases before the end of the first trimester) and partly on information from the antenatal care with respect to drugs prescribed later during the pregnancy by the attending doctor. | The Swedish Medical Birth Register, the Register of Birth Defects (previously known as the Register of Congenital Malformations) and the Patient Register (previous the Hospital Discharge Register). | Singleton only. Adjusted for pertinent variables, always including year of delivery, maternal age, parity, smoking, and body mass index (BMI). For PPHN: also restricted to infants with a gestational duration of at least 34 completed weeks. |
| Richardson, 2019 | prospective cohort | Upon contact with the service, information (including medication use) is collected from the health professional to allow accurate fetal risk assessment. | Postal questionnaires were sent to collect pregnancy and fetal outcome data from the healthcare professional who originally contacted the service. | No matched and adjustment for this comparison (SSRI versus no antidepressant). |
| Robinson-Wolrath, 2016 | retrospective cohort | Retrospective review of all pregnancies at King Edward Memorial Hospital, using midwifery and neonatal databases and case records. | Retrospective review of all pregnancies at King Edward Memorial Hospital, using midwifery and neonatal databases and case records. | Adjustment (NOS). |
| Roca, 2011 | prospective cohort | Cases were followed throughout pregnancy by a clinical researcher, who recorded the type and dosage of antidepressants at each visit. | Cases were followed prospectively and the assessment of controls was carried out by a clinical researcher during the postpartum hospital stay. | Exposed and non exposed groups matched by age (± 2 years) and parity. For preterm: logistic regression analysis used to control for a history of preterm, a history of elective or spontaneous abortions, and smoking during pregnancy. Other outcomes: no adjustment. |
| Rommel, 2022 | population based cohort retrospective | Information on antidepressant use during pregnancy was retrieved from the Danish National Prescription Registry. | Information on gestational age, birthweight, postnatal adaptation syndrome, persistent pulmonary hypertension of the neonate, neonatal admission and congenital malformations was obtained from the Danish National Patient Registry and the Danish Medical Birth Registry. | Singletons. Adjusted for maternal age at delivery, primiparity, maternal psychiatric history at delivery, maternal inpatient and outpatient treatment, dispensing of other psychotropic or antiepileptic prescriptions during pregnancy, number of maternal non- psychiatric hospital visits during pregnancy, smoking during pregnancy, marital status at delivery, highest education and year of delivery. |
| Sahingöz (Controls unexposed, disease free), 2014 | retrospective cohort | Identification of exposure when pregnant women were admitted to the psychiatry outpatient clinics (from the 36th gestational week to 8 weeks postpartum). | The examined outcomes related to newborns were obtained retrospectively or prospectively according to group of exposure. The gestational age was calculated on the basis of the date of last menstruation. Birth weight was provided from the hospital records and by mother reports. | None. |
| Sahingöz (Controls unexposed, sick), 2014 | retrospective cohort | Identification of exposure when pregnant women were admitted to the psychiatry outpatient clinics. | The examined outcomes related to newborns were obtained retrospectively or prospectively according to group of exposure. The gestational age was calculated on the basis of the date of last menstruation. Birth weight was provided from the hospital records and by mother reports. | None |
| Salisbury (Controls unexposed, disease free), 2016 | prospective cohort | Maternal self-report assessments during pregnancy. Cord blood samples were obtained at delivery for determination of plasma drug levels to confirm SSRI exposure. | Infant medical records were reviewed for Neonatal Intensive Care Unit admission and medical conditions. Infants were assessed with the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Certified examiners, blind to group status, conducted assessments on day 2, 4, 7, 14 and 30. | Model adjusted for covariates of gestational age at birth, infant sex, socioeconomic status and Inventory of Depressive Symptomatology. Only mothers not using illicit drugs, without medication for hypertension or diabetes, drinking less than one-half of a drink equivalent of alcohol per day and smoking less than 5 cigarettes per day in the first trimester with no smoking in the others. No preterm. |
| Salisbury (Controls unexposed, sick), 2016 | prospective cohort | Maternal self-report assessments during pregnancy. Cord blood samples were obtained at delivery for determination of plasma drug levels to confirm SSRI exposure. | Infant medical records were reviewed for Neonatal Intensive Care Unit admission and medical conditions. Infants were assessed with the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Certified examiners, blind to group status, conducted assessments on day 2, 4, 7, 14 and 30. | Model adjusted for covariates of gestational age at birth, infant sex, socioeconomic status and Inventory of Depressive Symptomatology. Only mothers not using illicit drugs, without medication for hypertension or diabetes, drinking less than one-half of a drink equivalent of alcohol per day and smoking less than 5 cigarettes per day in the first trimester with no smoking in the others. No preterm. |
| Salkeld, 2008 | nested case control | Prescription records identified using the Ontario Drug Benefit (ODB) database, which included comprehensive records of all prescription medications dispensed to Ontario residents receiving social assistance. | The Canadian Institute for Health Information Discharge Abstract Database, and the Ontario Health Insurance Plan database were used to identify claims for hospital visits and inpatient and outpatient physician services. | Controls were matched to cases on age, mode of delivery, number of deliveries in the 7 years preceding the index date, and calendar time. adjusted for previous postpartum hemorrhage, multiple pregnancy, prolonged labor, abnormalities of labor, perineal laceration or other gynecologic laceration, other obstetric trauma, placenta previa, placental abruption, and hypertensive disorders of pregnancy. |
| Scannell, 2020 | retrospective cohort | Not specified. | Not specified. | Patients with multiple gestations or fetal anomalies were excluded. Demographics were similar between groups (no further details). Adjusted OR but not details. |
| Simon (Controls exposed to TCA), 2002 | retrospective cohort (claims database) | Pharmacy records were used to identify all antidepressant prescriptions filled or refilled during the 360 days before delivery. | The infants’ medical records were used to examine perinatal outcomes, congenital malformations, early childhood neurological illness, and developmental delay. All information regarding prenatal exposures were masked of the chart reviewers. | No adjustment or match for this group of comparison. |
| Simon (Controls unexposed, NOS), 2002 | retrospective cohort (claims database) | Pharmacy records were used to identify all antidepressant prescriptions filled or refilled during the 360 days before delivery. | The infants’ medical records were used to examine perinatal outcomes, congenital malformations, early childhood neurological illness, and developmental delay. All information regarding prenatal exposures were masked of the chart reviewers. | Adjusted for maternal tobacco use, other substance use, race, and number of prior births. Unexposed selected taken into account to the following maternal characteristics: age, year of delivery, lifetime number of antidepressant prescriptions filled or refilled, lifetime history of psychiatric treatment, and length of Group Health Cooperative enrollment. |
| Sivojelezova - Citalopram, 2005 | prospective cohort | During an initial interview with a patient, a standardized intake form was completed over the telephone with information regard- ing general medical and obstetrical history, timing of drug exposure, and its dose schedule. | A follow-up telephone interview of all women was performed, consisted of a comprehensive list of questions with regard to maternal health during pregnancy, pregnancy outcome, delivery, and neonatal health. Then, a letter to the infant’s attending physician to corroborate the medical details. | Groups were matched for the maternal age at the time of conception as well as the gestational stage of pregnancy at the time of recruitment. |
| Sjaarda, 2020 | prospective cohort | Antidepressant medication exposure was measured in stored urine samples collected at study visits at enrollment and at the end of preconception follow-up. For women who became pregnant, samples from pregnancy visits at gestational weeks 4 and 8 were also evaluated. | Pregnancy loss was defined as any loss occurring after hCG detection of pregnancy. Live birth was ascertained by medical chart abstraction. | Models for all outcomes were adjusted for potential confounders including age, race, BMI, education, smoking, alcohol use, average daily perceived stress score during first study cycle, and opioid and tetrahydrocannabinoid exposure as determined by urine immunoassay or self-report. |
| Skalkidou (Controls unexposed, disease free), 2020 | population based cohort retrospective | Information on self-reported use of SSRI medication during pregnancy was collected at any of the 12 scheduled antenatal visits before delivery and entered by the caregiver in the maternal healthcare records. | Data are mainly collected directly from the electronic medical records. The total amount of bleeding is reported from the delivering midwife or obstetrician . | Adjusted for age, BMI, parity, prior Cesarienne Section, smoking, country of birth, occupation, delivery mode, polyhydramnios, birthweight >4000 g, dystocia, preterm delivery. |
| Skalkidou (Controls unexposed, sick), 2020 | population based cohort retrospective | Information on self-reported use of SSRI medication during pregnancy was collected at any of the 12 scheduled antenatal visits before delivery and entered by the caregiver in the maternal healthcare records. | Data are mainly collected directly from the electronic medical records. The total amount of bleeding is reported from the delivering midwife or obstetrician . | No adjustment for this group of comparison. |
| Skurtveit, 2014 | prospective cohort | Maternal self-reported drug use obtained prospectively several times during pregnancy. The validity of data was explored with the prescription data from the Norwegian Prescription Database (NorPD). A redeemed prescription of SSRI was found in NorPD for 93% of the women who reported such use in MoBa. | Language competence at age 3 years was determined by a language grammar rating scale in the 3-year questionnaire completed by mother. | Singleton only. Adjusted fo maternal depression before pregnancy, symptoms of anxiety/depression in pregnancy and maternal work situation, parity, marital status, smoking, body mass index and maternal and paternal education. Exclusion of children with malformations and/or chromosomal abnormalities. |
| Smith, 2013 | prospective cohort | A structured screening questionnaire collected information about pregnancy dates and antidepressant treatment was administrated during pregnancy. | After delivery, a trained assessor who was blind to maternal antidepressant use evaluated neonates using the Neonatal Behavioral Assessment Scale (NBAS). Medical records were reviewed and information on other infant exposures and APGAR scores was abstracted by trained medical record reviewers. | None. |
| Solé, 2020 | nested case control | Women were followed throughout pregnancy by a clinical researcher, who recorded the type and dosage of medications during pregnancy and information about concurrent medical illness. | Obstetric and medical histories were obtained for all women by systematic review of obstetric records and prenatal care. | None. |
| Stephansson, 2013 | population based cohort retrospective | The prescription registries in the Nordic countries include data on the dispensed item, substance, brand name, and formulation together with date of dispensing for more than 95% of the total outpatient population. | Information on stillbirth was obtained from the medical birth registries and neonatal and postneonatal deaths were obtained from the Nordic causes of death registries. All diagnoses and causes of death are classified according to the ICD-10 codes. | Adjusted for country and year of birth, maternal age, birth order, smoking in early pregnancy, and maternal diabetes and hypertension. |
| Suarez (Controls unexposed, discontinuers), 2022 | retrospective cohort (claims database) | The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), that include information on dispensed outpatient prescription medications. | The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), that include information on diagnoses, and procedures received during all health care encounters, including all inpatient, out-patient, or emergency department visits. | Illness. Adjusted for age, race/ethnicity (MAX only), delivery year, antidepressant indications, proxies for severity of mental conditions, smoking, alcohol/substance abuse, other medications, overweight/obesity, pregestational diabetes, pregestational hypertension, county-level socioeconomic indicators (MAX only), prenatal vitamin use, multiple gestation pregnancy, parity (MAX only), ... |
| Suarez (Controls unexposed, general pop), 2022 | retrospective cohort (claims database) | The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), that include information on dispensed outpatient prescription medications. | The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), that include information on diagnoses, and procedures received dur- ing all health care encounters, including all inpatient, out- patient, or emergency department visits. | Adjusted for age, race/ethnicity (MAX only), delivery year, antidepressant indications, proxies for severity of mental conditions, smoking, alcohol/substance abuse, other medications, overweight/obesity, pregestational diabetes, pregestational hypertension, county-level socioeconomic indicators (MAX only), prenatal vitamin use, multiple gestation pregnancy, parity (MAX only), ... |
| Sujan (Controls unexposed, NOS), 2017 | population based cohort retrospective | Exposure was defined according to 2 sources of information: maternal self-reports (available from the Medical Birth Register for offspring born between 1996 and 2012) and dispensation records (from the Prescribed Drug Register; available for both parents of offspring born between 2006 and 2012). | Birth outcomes were identified using inpatient and outpatient diagnoses made by specialists according to International Classification of Diseases, Ninth Revision (ICD-9) and ICD-10 criteria. | Singletons only. Adjusted models controlled for parity, year of birth, maternal and paternal, country of birth, age at childbearing, highest level of completed education, history of any criminal convictions, history of severe psychiatric illness, and history of any suicide attempts. |
| Sujan (Controls unexposed, sibling), 2017 | population based cohort retrospective | Exposure was defined by maternal self-reports (available from the Medical Birth Register for offspring born between 1996 and 2012). | Birth outcomes were identified using inpatient and outpatient diagnoses made by specialists according to International Classification of Diseases, Ninth Revision (ICD-9) and ICD-10 criteria. | Sibling comparisons controlled for parity, year of birth, paternal country of birth, age at childbearing, highest level of completed education, history of any criminal convictions, history of severe psychiatric illness, history of any suicide attempts, and maternal age at childbearing. |
| Suri, 2007 | prospective cohort | Participants underwent assessments on a monthly basis throughout their pregnancy. Participants were also seen by the study physician for a clinical assessment, which included collection of information about medications taken and medication dosages. | Obstetrical and hospital records were obtained for all participants. | None. |
| Suri - Fluoxetine (Controls unexposed, disease free), 2004 | prospective cohort | Subjects recruited in the first trimester of pregnancy and that were then followed once in each trimester (NOS). | Not specified. | None. |
| Suri - Fluoxetine (Controls unexposed, sick), 2004 | prospective cohort | Subjects recruited in the first trimester of pregnancy and that were then followed once in each trimester (NOS). | Not specified. | None. |
| Sørensen (Controls exposed to TCA), 2013 | population based cohort retrospective | The Danish National Prescription Registry (DNPR) that holds information on prescriptions filled, written by a general practitioner or medical specialist. | Diagnoses are reported to the Danish Psychiatric Central Register (DPCR) from Danish child and adolescent psychiatric clinics where clinical assessment is made by a specialized team including child psychiatrists and psychologists. | No adjustment for this group of comparison. |
| Sørensen (Controls unexposed, NOS), 2013 | population based cohort retrospective | The Danish National Prescription Registry (DNPR) that holds information on prescriptions filled, written by a general practitioner or medical specialist. | Diagnoses are reported to the Danish Psychiatric Central Register (DPCR) from Danish child and adolescent psychiatric clinics where clinical assessment is made by a specialized team including child psychiatrists and psychologists. | Hazard ratios were adjusted for maternal age at conception, paternal age at conception, parental psychiatric history (except maternal affective disorder), gestational age, birth weight, sex, and parity. |
| Sørensen (Controls unexposed, sibling), 2013 | population based cohort retrospective | The Danish National Prescription Registry (DNPR) that holds information on prescriptions filled, written by a general practitioner or medical specialist. | Diagnoses are reported to the Danish Psychiatric Central Register (DPCR) from Danish child and adolescent psychiatric clinics where clinical assessment is made by a specialized team including child psychiatrists and psychologists. | Sibling design. Hazard ratios were adjusted for maternal age at conception, paternal age at conception, gestational age, birth weight, sex, and parity. |
| Sørensen (Controls unexposed, sick), 2013 | population based cohort retrospective | The Danish National Prescription Registry (DNPR) that holds information on prescriptions filled, written by a general practitioner or medical specialist. | Diagnoses are reported to the Danish Psychiatric Central Register (DPCR) from Danish child and adolescent psychiatric clinics where clinical assessment is made by a specialized team including child psychiatrists and psychologists. | Illness. Hazard ratios were adjusted for maternal age at conception, paternal age at conception, parental psychiatric history (except maternal affective disorder), gestational age, birth weight, sex, and parity. |
| Talati (Controls unexposed, general pop), 2025 | - | |||
| Talati (Controls unexposed, sick), 2025 | - | |||
| Ter Host (Controls exposed to TCA), 2013 | retrospective cohort (claims database) | The pharmacy prescription database IADB.nl which contains pharmacy prescription data of an estimated population of 500 000 individuals from the Netherlands. | The drugs for pulmonary diseases in children were used as a proxy for developmental respiratory tract changes in children: beta-2 selective sympathomimetics (ATC: R03CC, R03AC), inhalation corticosteroids (ATC: R03BA), combined inhalation drugs (ATC: R03AK), and leucotriene antagonists (ATC: R03DC). | No adjustment for this group of comparison. |
| Ter Host (Controls unexposed, NOS), 2013 | retrospective cohort (claims database) | The pharmacy prescription database IADB.nl which contains pharmacy prescription data of an estimated population of 500 000 individuals from the Netherlands. | The drugs for pulmonary diseases in children were used as a proxy for developmental respiratory tract changes in children: beta-2 selective sympathomimetics (ATC: R03CC, R03AC), inhalation corticosteroids (ATC: R03BA), combined inhalation drugs (ATC: R03AK), and leucotriene antagonists (ATC: R03DC). | Adjusted for maternal antibiotic use. |
| Toh a, 2009 | retrospective cohort | Within 6 months of delivery, trained nurses who were unaware of the study hypotheses conducted a 45- to 60-minute telephone interview with the participating mothers, notably to collect data regarding medications taken any time from 2 months prior to conception throughout pregnancy. | Women were specifically asked whether a healthcare provider had diagnosed them with high blood pressure or preeclampsia/ toxemia during their pregnancy, and if so, the dates when the condition started and ended and whether medication was used to treat the condition. | Data adjusted for region, maternal age, race/ethnicity, marital status, family income, age at menarche, diabetes mellitus, cigarette smoking, prepregnancy body mass index, treatment with non-SSRI antidepressants, number of fetuses, gravidity, and history of fertility. |
| Toh b, 2009 | retrospective cohort | Within 6 months of delivery, trained nurses who were unaware of the study hypotheses conducted a 45- to 60-minute telephone interview with the participating mothers, notably to collect data regarding medications taken any time from 2 months prior to conception throughout pregnancy. | Not specified. | Adjusted for maternal age, race/ethnicity, prepregnancy hypertension, cigarette smoking, use of other psychotherapeutic drugs, and number of fetuses. |
| Tran (Controls exposed to TCA), 2022 | retrospective cohort (claims database) | The PHARMO Database Network, a population-based network of healthcare databases combining data from hospital and community pharmacies in the Netherlands, including the ATC classification of the drug, start and end date of use, strength, dosage regimen and route of administration. | The Netherlands Perinatal Registry (PRN, or named PERINED) | No adjusted for this group of comparison. |
| Tran (Controls unexposed, NOS), 2022 | retrospective cohort (claims database) | The PHARMO Database Network, a population-based network of healthcare databases combining data from hospital and community pharmacies in the Netherlands, including the ATC classification of the drug, start and end date of use, strength, dosage regimen and route of administration. | The Netherlands Perinatal Registry (PRN, or named PERINED) | Adjusted for maternal age, ethnicity, alcohol consumption, smoking during pregnancy, any endocrine disorders and concurrent use of vaso- constrictors. |
| Ulbrich, 2021 | retrospective cohort | Data were obtained through the electronic Enterprise Data Warehouse, which extracts information directly from the patient electronic health records. | Data were obtained through the electronic Enterprise Data Warehouse, which extracts information directly from the patient electronic health records. | Full-term singleton newborn. Adjusted analysis was based on a list of prespecified clinically meaningful covariates (mother’s smoking status, infant race, gestational age, and benzodiazepine exposure). An additional method of controlling for several confounders simultaneously via inverse probability weighting was performed using propensity scores (PS). |
| Van der Veere, 2020 | prospective cohort | Not specified (but prospective cohort). | Children assessed at age 2.5 years using the Bayley Scales of Infant and Toddler Development (BSID, 3rd Edition). The examiner was blinded for maternal mental state and use of SSRI during pregnancy. Parents filled out the Child Behavior Checklist (CBCL). | None (adjusted for maternal depression and anxiety and maternal education, gender, gestational age, birth weight, severity of maternal depression and anxiety, but results not extractable). |
| Vasilakis-Scaramozza (Controls exposed to TCA), 2013 | retrospective cohort | Clinical records that described prescribed drugs from each clinical visit. | Computerized medical record that recorded all congenital anomalies noted in the patient’s clinical records. | No match nor adjustment for this group of comparison. |
| Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 | retrospective cohort (claims database) | Clinical records that described prescribed drugs from each clinical visit. | Computerized medical record that recorded all congenital anomalies noted in the patient’s clinical records. | Control group matched by age, year of pregnancy outcome, and general practice. Adjustment for potential confounders (prepregnancy body mass index, maternal age, cigarette smoking status, history of diabetes mellitus, insulin use, exposure to a teratogen during the first trimester, history of infertility and premature delivery) if its changed the crude relative risk estimate by more than 10%. |
| Vial - Paroxetine, 2006 | prospective cohort | Maternal data and detailed history of drug exposures were collected during the first contact for individual risk counseling. | Follow-up of pregnancies were prospectively documented. | Women were matched for gestational age at the time of request. |
| Viktorin, 2017 | population based cohort retrospective | The Swedish Prescribed Drug Register that contains information on all dispensed prescription medications in Sweden. | A clinically ascertained diagnosis of intellectual disability (ID) was identified in the Swedish National Patient Register. Intellectual disability was defined as having at least 1 inpatient or outpatient specialist care admission with an ICD-10 code of F70 to F79. | Adjusted for birth date, maternal and paternal age, the father's psychotropic medication use that overlapped the pregnancy, maternal and paternal educational levels at childbirth, and for maternal and paternal diagnoses before childbirth of specific psychiatric disorder subgroups. |
| Viktorin b, 2017 | population based cohort retrospective | Dispensations identified in the Swedish Prescribed Drug Register that holds information on all dispensed prescription drugs in Sweden. | A clinically ascertained diagnosis of offspring Autism spectrum disorder (ASD) was identified in the Swedish Patient Register, with an ICD-10 code according to: F84.0, F84.1, F84.2, F84.3, F84.4, F84.5, F84.8, or F84.9. | Adjusted for birthdate, maternal and paternal age, the father's psychotropic medication overlapping the pregnancy, the mother's one-time dispensations of antidepressant and/or other psychotropic medication that overlapped the pregnancy, for any diagnosis of depression in the mother's lifetime, for any diagnosis of psychiatric disorder subgroups in either the mother and/or father's life time. |
| Wall-Wieler, 2020 | retrospective cohort (claims database) | Antidepressant prescriptions were identified from outpatient pharmacy files through National Drug Codes (NDC) from outpatient pharmaceutical claims. | IBM databases with link between inpatient services, outpatient services, outpatient pharmacy prescription claims, and healthcare plan enrollment information. | High-dimensional propensity score adjustments including 500 variables, notably the year of pregnancy, women’s age at the end of the pregnancy, and 5 predefined conditions identified as being risk factors for ectopic pregnancy: pelvic infections, sexually transmitted infections, assisted reproductive technology, intrauterine devices, and smoking in the year before a woman’s last menstrual period. |
| Wemakor, 2015 | case control | Medication exposure information came from maternal medical/midwifery notes, created prospectively. Other additional data sources include paediatrician records (postnatal), medical geneticist records (postnatal), GP records of mother (prenatal), and maternal interviews (postnatal). | EUROCAT registries collect data using multiple sources of information: maternity, neonatal, and paediatric records; fetal medicine, cytogenetic, pathology, and medical genetics records; paediatric cardiology services; and hospital discharge and child health records. ICD 9 or 10 classification. | Analyses were adjusted for registry in order to adjust for confounding that may arise if registries differ in both exposure and outcome prevalences. |
| Wen, 2006 | retrospective cohort (claims database) | The Saskatchewan Health databases including prescription information. | Live births and stillbirths linked with physician and hospital data files. Birth defects were coded by the International Classification of Diseases 9th Revision (ICD-9) codes. | Nonexposed women were individually matched to exposed subject (4:1) by year of birth, type of institute at birth and the first 3 digits of the mother’s postal code. Multiple logistic regression analyses including maternal age, receipt of provincial social assistance, drug dependence, parity and multigestation. For use of mechanical ventilation and infant death, also adjusted for gestational age. |
| Wichman, 2009 | retrospective cohort | The Division of Obstetrics prospectively maintains an obstetric deliveries database that was used to aid with the medical record review. The obstetric database listed the medications a woman took during her pregnancy. Each case was then confirmed by review of each individual medical record. | Infant outcomes are listed as part of the obstetric data- base. The database was searched for any of these diagnoses and confirmed by individual medical record review. | None. |
| Wilson, 2011 | case control | Prescription medication use was captured in three ways: a computerized database of all medications filled in our system; review of each patient’s outpatient antepartum electronic medical records (EMR); and review of each patient’s inpatient EMR generated at the time of admission for delivery. | Review of electronic medical records. The records of all infants who were diagnosed with PPHN were reviewed by an experienced neonatologist. | Adjusted for maternal diabetes, smoking, obesity, parity, advanced maternal age, chorioamnionitis, fetal gender and mode of delivery. |
| Wisner (Controls unexposed, disease free), 2009 | prospective cohort | Maternal assessments were completed at weeks 20, 30, and 36 weeks of gestation. SSRI exposure was documented by charting each subject’s drug doses across each week of gestation. For inclusion in the SSRI-treated groups, exposure was confirmed with maternal serum level. | Delivery records were reviewed and the newborns examined at 2 weeks postpartum. | Adjusted model includes maternal age and race. |
| Wisner (Controls unexposed, sick), 2009 | prospective cohort | Maternal assessments were completed at weeks 20, 30, and 36 weeks of gestation. SSRI exposure was documented by charting each subject’s drug doses across each week of gestation. For inclusion in the SSRI-treated groups, exposure was confirmed with maternal serum level. | Delivery records were reviewed and the newborns examined at 2 weeks postpartum. | None for this group of comparison. |
| Wu, 2019 | prospective cohort | All women were assessed for antidepressant use in the first trimester interview, with an extensive telephone interview conducted near the end of the first trimester of pregnancy. | Pregnancy outcomes were self-reported by participants and verified by medical or vital records. All spontaneous abortion cases were clinically confirmed, and all participants had research ultrasounds to assist with accurate dating. | Multivariable Cox proportional hazard models adjusted for maternal age, alcohol use, vitamin use, and calendar year of pregnancy. Sensitivity analysis additionally adjusting for prior history of spontaneous abortion. Women who use assisted reproductive technologies were eligible for recruitment. No effect modification with age, BMI, smoking status, alcohol consumption status, and race-ethnicity. |
| Yang, 2021 | retrospective cohort (claims database) | The Health and Welfare Database (HWD), administrative claims database that incorporates prescription drug utilization. | The Health and Welfare Database (HWD) and the Birth Certificate Application (BCA) administrative databases that incorporates patient diagnoses (coded according to ICD-9 or 10). | Characteristics (demographic variables (as age and region), the presence of comorbid diseases (included obesity, diabetes, renal diseases, liver diseases, epilepsy, substance use disorder, autoimmune diseases, ...), medication-related variables, and severity of depression) considered imbalanced between the 2 groups were further adjusted for in the regression analyses. |
| Yang (Controls unexposed, disease free), 2017 | prospective cohort | Mothers belonged to one of 3 groups based on exposure status during pregnancy (NOS). | A medically trained study team member examined the infant. For those signs that could not be assessed in a single observation, parental report was used. The personnel conducting the Finnegan assessments were blind to the prenatal exposure status and the mother’s psychiatric diagnosis (if any). | None |
| Yang (Controls unexposed, sick), 2017 | prospective cohort | Mothers belonged to one of 3 groups based on exposure status during pregnancy (NOS). | A medically trained study team member examined the infant. For those signs that could not be assessed in a single observation, parental report was used. The personnel conducting the Finnegan assessments were blind to the prenatal exposure status and the mother’s psychiatric diagnosis (if any). | None |
| Yaris, 2005 | prospective cohort | Data surveyed by the interviews. | Examinations were made by obstetric ultrasound for the mothers and birth weight and height, gestational age, APGAR scores, congenital malformation and developmental problems for the babies. Periodic checks of all the babies in the neonatal period, were made the first year, and following years. | None for this group of exposure. |
| Yazdy, 2014 | case control | The telephone interview were conducted by trained nurses within 1 year after delivery. It consisted in questions notably on illnesses and medications. If a mother reported using any medications, the timing and indication for use were noted. | Diagnosis of structural clubfoot was confirmed primarily by orthopedic records (77%); when medical records were not available, maternal report of 3 or more castings for the clubfoot was used to confirm a true structural clubfoot (23%). | Adjusted for maternal smoking, alcohol use, and body mass index. |
| Yeh, 2021 | retrospective cohort (claims database) | The Taiwan National Health Insurance Research Database (THIRD) provides prescriptions information about insured individuals. | The THIRD provides diagnosis information about insured individuals. Psychiatric disorders were diagnosed based on clinical judgement and interviews by psychiatrists. In this study, the diagnosis of ADHD and ASD required at least twice outpatient visits within each year for these ICD-9 codes. | Adjusted for demographic characteristics (the level of urbanization, monthly income, and other demographics). |
| Zakiyah, 2018 | retrospective cohort (claims database) | The University of Groningen’s IADB.nl pharmacy prescription database, a longitudinal database containing pharmacy-dispensing data from community pharmacies in the Netherlands. | The outcome was determined by identifying dispensed antihypertensive drugs to treat gestational hypertension. A woman was considered to have gestational hypertension when she had at least one prescription for methyldopa, nifedipine, labetalol, ketanserin, or nicardipine. | Adjusted for maternal age and medications use during pregnancy i.e. prescriptions of benzodiazepines and antibiotics. |
| Zeskind, 2004 | retrospective cohort | Used SSRIs during pregnancy determined according to medical records. | A review of medical records for outcomes of deliveries. All neurobehavioral ratings were conducted by an assistant who was trained to criterion and masked to SSRI group membership. | Controls matched on maternal cigarette use (n=5 per group), maternal age (plus/minus 2 years), and low socioeconomic status (SES), as measured by determined need of public medical insurance (Medicaid; n = 3 per group). Neurobehavioral scores also adjusted for gestational age. |
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