Study | Country Study period Study design |
Data source | Exposure definition | Non-exposure definition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
---|---|---|---|---|---|---|---|---|
Battino (Acetazolamide) (Epilepsy) 2024 |
Worldwide (47 countries) 1999 - 2022 prospective cohort |
The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). | Pregnant women with epilepsy exposed to Acetazolamide monotherapy at the time of conception. |
exposed to other treatment, sick
Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception. |
early pregnancy | 2 / 3584 | Overlapping/Update: Malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Tomson 2011 and Jimenez 2020 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) monotherapies studied. | |
Reporting physicians collected information on drug therapy after each trimester. | ||||||||
Christensen (Acetazolamide) (All indications) (Controls exposed to LTG) 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 population based cohort retrospective |
Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project. | Children of mothers who had redeemed at least one prescription of Acetazolamide monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
exposed to other treatment, sick
Children of mothers who had redeemed at least one prescription of Lamotrigine monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
during pregnancy (anytime or not specified) | 127 / 8756 | Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017). | |
Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing. | ||||||||
Christensen (Acetazolamide) (All indications) (Controls unexposed, general population) 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 population based cohort retrospective |
Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project. | Children of mothers who had redeemed at least one prescription of Acetazolamide monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
unexposed (general population or NOS)
Children of mothers who had not redeemed prescription of anti-seizure medication. |
during pregnancy (anytime or not specified) | 127 / 4467848 | Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017). | |
Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing. | ||||||||
Samrén (Acetazolamide) 1999 |
Netherlands 1972 - 1994 retrospective cohort |
28 hospitals in four provinces of the Netherlands and National Perinatal Data Base LVR. | Children born to mothers with epilepsy and using acetazolamide monotherapy at least during the first trimester of pregnancy |
unexposed, disease free
Children born to nonepileptic nonexposed women. |
at least 1st trimester | 1 / 2000 | ||
Data were collected from medical records and include medication. The prescribed dose of thedrugs was also retrieved from obstetric files. | ||||||||
Vajda (Acetazolamide) (Controls exposed to Lamotrigine, sick) 2019 |
Australia 1999 - 2018 prospective cohort |
The Australian Register of Antiepileptic Drugs in Pregnancy. | Offsprings born from women nearly always with epilepsy exposed to acetazolamide in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Offsprings born from women nearly always with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy. |
at least 1st trimester | 1 / 406 | Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013. Jazayeri 2018 malformations results are completely overlap by Vajda 2019. | |
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records. | ||||||||
Vajda (Acetazolamide) (Controls unexposed, sick) 2019 |
Australia 1999 - 2018 prospective cohort |
The Australian Register of Antiepileptic Drugs in Pregnancy. | Offsprings born from women nearly always with epilepsy exposed to acetazolamide in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offsprings born from women nearly always with epilepsy not treated with antiepileptic drugs in at least the first half of pregnancy. |
at least 1st trimester | 1 / 176 | Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013. Jazayeri 2018 malformations results are completely overlap by Vajda 2019. | |
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records. |
Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
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Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;