| 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 |
|---|---|---|---|---|---|---|---|---|
|
Andersen 2014 |
Denmark 1997 - 2010 population based cohort retrospective |
The Danish administrative health registries and linked through the CPR-number, a unique identification number given to all citizens. | Pregnant women dispensing of a prescription of Escitalopram (at least the first 35 days of pregnancy). |
unexposed (general population or NOS)
Pregnant women without dispensation of Selective Serotonin Reuptake Inhibitors (SSRIs) during the first 35 days of pregnancy. |
early pregnancy | 2377 / 1256956 | ||
| 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. | ||||||||
|
Ban (Controls unexposed, disease free) 2014 |
United Kingdom 1990 - 2009 retrospective cohort (claims database) |
The Health Improvement Network (THIN), a nationally representative database of computerised primary care records. | Pregnant women with Escitalopram prescriptions from 4 weeks before to 12 weeks after the first day of the estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnant women without diagnosis of depression. |
1st trimester | 333 / 325294 | Exclusion of 9096 children (2.5% of the study population) whose mothers had bipolar disorder, schizophrenia, other serious psychotic disorders, or prescriptions for antimanic and antipsychotic drugs before childbirth. | |
| The Health Improvement Network (THIN), a nationally representative database that contains drug prescriptions. | ||||||||
|
Ban (Controls unexposed, sick) 2014 |
United Kingdom 1990 - 2009 retrospective cohort (claims database) |
The Health Improvement Network (THIN), a nationally representative database of computerised primary care records. | Pregnant women with Escitalopram prescriptions from 4 weeks before to 12 weeks after the first day of the estimated last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with diagnosed depression (in the year before conception up to the end of the first trimester) but with no antidepressant drug prescriptions in the first trimester. |
1st trimester | 933 / 13432 | Exclusion of 9096 children (2.5% of the study population) whose mothers had bipolar disorder, schizophrenia, other serious psychotic disorders, or prescriptions for antimanic and antipsychotic drugs before childbirth. | |
| The Health Improvement Network (THIN), a nationally representative database that contains drug prescriptions. | ||||||||
|
Chan (Controls exposed to TCA) 2024 |
China 2003 - 2018 retrospective cohort (claims database) |
The Clinical Data Analysis and Reporting System (CDARS), an electronic health-record database developed by the Hospital-Authority which is a statutory body delivering government-subsidized, universal health coverage to all Hong Kong residents. | Infants of women with prescription of Escitalopram only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
exposed to other treatment, sick
Infants of women with prescription of Tricyclic antidepressants (TCA) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
1st trimester | 47 / 322 | ||
| Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | ||||||||
|
Chan (Controls unexposed, pop general) 2024 |
China 2003 - 2018 retrospective cohort (claims database) |
The Clinical Data Analysis and Reporting System (CDARS), an electronic health-record database developed by the Hospital-Authority which is a statutory body delivering government-subsidized, universal health coverage to all Hong Kong residents. | Infants of women with prescription of Escitalopram only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. |
unexposed (general population or NOS)
Infants of pregnant women who were not prescribed with any antidepressant within 90 days before the last menstrual period and during the first trimester. |
1st trimester | 47 / 462377 | ||
| Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | ||||||||
|
Colvin 2012 |
Australia 2002 - 2005 retrospective cohort (claims database) |
A population-based study of all pregnancy events in Western Australia (WA). | Children born to women who had been dispensed Escitalopram at any time during their pregnancy. |
unexposed (general population or NOS)
Children born to women who had not been dispensed a selective serotonin reuptake inhibitor (SSRI) at any time during their pregnancy. |
during pregnancy (anytime or not specified) | -9 / 94561 | Nb of exposed children not reported. | |
| The national Pharmaceutical Benefits Scheme (PBS), a claims database that includes 80% of all prescriptions dispensed in Australia. | ||||||||
|
Cornet 2024 |
USA 2011 - 2019 retrospective cohort (claims database) |
The 15 Kaiser Permanente Northern California (KPNC) hospitals. | Infants with any maternal Escitalopram monotherapy (among Selective serotonin reuptake inhibitor (SSRI)) dispensing by a KPNC pharmacy during late pregnancy, that is, after 20 weeks’ gestation. |
unexposed (general population or NOS)
Infants with no maternal Selective serotonin reuptake inhibitor (SSRI) dispensing by a KPNC pharmacy during late pregnancy, that is, after 20 weeks’ gestation. |
late pregnancy | 382 / 272517 | Dose-dependent relationship of individuals substances: no conclusion provided by authors. | |
| Prescription files of Kaiser Permanente Northern California pharmacies. For each prescription, dispensation date, daily dosage and number of pills dispensed were collected. | ||||||||
|
Einarson 2009 |
Canada Not specified. prospective cohort |
The Motherisk Program, a teratogenic information service. | Pregnant women who were exposed to Escitalopram in the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who were not exposed to antidepressants and who had called Motherisk for information regarding nonteratogenic drugs. |
1st trimester | 21 / 928 | ||
| During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire. | ||||||||
|
Furu 2015 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2010 population based cohort retrospective |
Nordic population (Denmark, Finland, Iceland, Norway, and Sweden) identified from nationwide health registers. | Infants born to women who filled a prescription for Escitalopram from 30 days before the first day of the last menstrual period until the end of the first trimester (defined as 97 days after the LMP). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants not exposed to any antidepressant (ATC code N06A) in utero. |
1st trimester | 3950 / 2266875 | ||
| The Nordic prescription registers include data on dispensed drugs, substance, brand name, and formulation, together with date of dispensing. | ||||||||
|
Heuvelman 2023 |
United Kingdom 1995 - 2017 retrospective cohort (claims database) |
The UK Clinical Practice Research Datalink, a large, ongoing database of anonymised primary care medical records for patients registered with a general practice in the United Kingdom. | Women who had initiated or continued Escitalopram for the treatment of depressive symptoms during pregnancy. |
unexposed, sick
Women who did not initiate or who discontinue antidepressants during pregnancy. |
during pregnancy (anytime or not specified) | 546 / 16330 | Dose–response relationships, sibling design and negative control for antidepressants use as a whole (not for the class of antidepressants). | |
| 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). | ||||||||
|
Jimenez-Solem (Controls unexposed, NOS) 2012 |
Denmark 1997 - 2009 population based cohort retrospective |
Register-based retrospective nationwide cohort study, using the Danish Medical Birth Registry. | Pregnancies with a continuous exposure to Escitalopram at least 1 month before conception until day 84 of pregnancy (last day of the first trimester). |
unexposed (general population or NOS)
Pregnancies with no exposure to a selective serotonin reuptake inhibitor (SSRI) during pregnancy. |
1st trimester | 293 / 843797 | Overlapping: this study included data published by Kornum 2010. Overlapping: Data related to Major and cardiac malformations not reported because an overlapping Furu 2015 a larger study including data from 5 nordic countries, including Denmark. | |
| The drug redemptions were identified using the Register of Medicinal Product Statistics which has recorded drugs dispensed from Danish pharmacies. | ||||||||
|
Jimenez-Solem (Controls unexposed, sick) 2012 |
Denmark 1997 - 2009 population based cohort retrospective |
Register-based retrospective nationwide cohort study, using the Danish Medical Birth Registry. | Pregnancies with a continuous exposure to Escitalopram, at least 1 month before conception until day 84 of pregnancy (last day of the first trimester). |
unexposed, sick
Pregnancies with paused exposure during pregnancy (an SSRI 3-12 months before conception and 1-12 months after giving birth but with no expo- sure to an SSRI between 3 months before conception to 1 month after giving birth). |
1st trimester | 293 / 806 | Overlapping: this study included data published by Kornum 2010. Overlapping: Data related to Major and cardiac malformations not reported because an overlapping Furu 2015 a larger study including data from 5 nordic countries, including Denmark. | |
| The drug redemptions were identified using the Register of Medicinal Product Statistics which has recorded drugs dispensed from Danish pharmacies. | ||||||||
|
Jordan 2016 |
Norway, Wales and Denmark. 2000 - 2010 retrospective cohort (registry) |
Three population-based EUROCAT congenital anomaly registries- Norway, Wales and Funen, Denmark. | Prescription of Escitalopram in the 91 days either side of the 1st day of last menstrual period (LMP). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
No prescription of selective serotonin reuptake inhibitors (SSRIs) during pregancy. |
3 months or more before pregnancy or1st trimester | 3236 / 506155 | Overlapping: The results of outcomes also reported in the largest study published by Wemakor 2015 (EUROCAT data in 12 countries; 1995-2009) are not reported here. Overlapping: Jordan 2016 included results of Knudsen 2014. | |
| 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). | ||||||||
|
Källén 2007 |
Sweden 1995 - 2004 population based cohort retrospective |
The Swedish Medical Birth Register, the Register of Congenital Malformations, and the Hospital Discharge Register. | Pregnant women who reported the use of Escitalopram in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
The total population. |
early pregnancy | 70 / 873876 | Overlapping: Kallen 2007 included results of 'Any malformations' published by Kallen 2006. All malformations: no overlapping with Furu 2015 (including Sweden 2006-2010). | |
| 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. | ||||||||
|
Kieler 2012 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2007 population based cohort retrospective |
Population based cohort study using data from the national health registers from the five Nordic countries. | A filled prescription of Escitalopram during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
No filled prescription of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. |
2nd and/or 3rd trimester, 3 months or more before pregnancy or1st trimester | 3247 / 1588140 | ||
| The prescription registers. | ||||||||
|
Klieger-Grossmann 2012 |
Canada, Switzerland and Italy Not specified. prospective cohort |
The Motherisk Program in Toronto, the Swiss Teratogen Information Service, and the Florence Teratogen Information Service. | Pregnant women exposed to escitalopram during pregnancy. |
unexposed (general population or NOS)
Pregnant women who called for nonteratogenic exposures such as acetaminophen, antibiotics, anti- histamines, and so on. |
1st trimester, during pregnancy (anytime or not specified), late pregnancy | 213 / 212 | The 21 exposures to escitalopram that were part of a larger prospective study from Motherisk (Einarson 2009) were excluded from this study. Results versus other antidepressants (SSRIs, venlafaxine, mirtazapine...) not reported => inadequate control group. | |
| 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. | ||||||||
|
Kolding (Controls unexposed, disease free) 2021 |
Denmark 2007 - 2014 population based cohort retrospective |
Five nationwide registries and databases: the Danish Fetal Medicine Database, the Danish National Patient Registry, the Danish Medical Birth Registry and the Danish Health Services Prescription Database. | Pregnant women with two or more redeemed prescriptions of Escitalopram from 28 days before through 70 days after the conception date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnant women with absence of redemptions for an antidepressant in the same time window, combined with absence of former use. |
1st trimester | 308 / 353581 | 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.' | |
| Exposure to antidepressants was measured using redeemed prescriptions through linkage to the Danish Health Services Prescription Database. | ||||||||
|
Kolding (Controls unexposed, sick) 2021 |
Denmark 2007 - 2014 population based cohort retrospective |
Five nationwide registries and databases: the Danish Fetal Medicine Database, the Danish National Patient Registry, the Danish Medical Birth Registry and the Danish Health Services Prescription Database. | Pregnant women with two or more redeemed prescriptions of Escitalopram from 28 days before through 70 days after the conception date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with untreated- or well treated depression or anxiety without antidepressant use in the pregnancy (one or more redeemed prescription of an antidepressant from 365 to 183 days preconception and no redemptions between 182 days preconception through the first trimester). |
1st trimester | 308 / 6326 | 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.' | |
| Exposure to antidepressants was measured using redeemed prescriptions through linkage to the Danish Health Services Prescription Database. | ||||||||
|
Lee (Controls exposed to TCAs) 2025 |
China 2003 - 2018 retrospective cohort (claims database) |
The Clinical Data Analysis and Reporting System (CDARS) of the Hospital Authority, Hong Kong. | Women filling at least one prescription of Escitalopram only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery. |
exposed to other treatment, sick
Women filling at least one prescription of any tricyclic antidepressants (TCA) only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery. |
during pregnancy (anytime or not specified) | 71 / 613 | ||
| The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records. | ||||||||
|
Lee (Controls unexposed, general pop) 2025 |
China 2003 - 2018 retrospective cohort (claims database) |
The Clinical Data Analysis and Reporting System (CDARS) of the Hospital Authority, Hong Kong. | Women filling at least one prescription of Escitalopram only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery. |
unexposed (general population or NOS)
Women who were not prescribed with any antidepressant during index pregnancy. |
during pregnancy (anytime or not specified) | 71 / 463440 | ||
| The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records. | ||||||||
|
Liu 2017 |
Denmark 1998 - 2012 population based cohort retrospective |
Data from Danish national registers | A prescription of Escitalopram monotherapy dispensed on any date from one month before pregnancy until delivery. (This is a subgroup of exposure among the whole exposed group considered). |
unexposed, sick
Antidepressant discontinuation (use before but not during pregnancy). |
during pregnancy (anytime or not specified) | 868 / 30079 | Results for Psychiatric disorders (ICD-10 codes F00-F99) in the offspring (mean age at diagnosis: 8.5 years) not reported here because not only neurodevelopmental disorders but also psychiatric disorders. | |
| Information on antidepressant use came from the Danish National Prescription Registry, that covers all prescriptions dispensed in Denmark since 1995. | ||||||||
|
Malm 2011 |
Finland 1996 - 2006 population based cohort retrospective |
An ongoing national joint project, Drugs and Pregnancy, based on three national health registers: The Medical Birth Register and the Register of Congenital Malformations and the Drug Reimbursement Register. | Offspring of mothers with at least one purchase of Escitalopram during the period of 1 month before pregnancy and first trimester. |
unexposed (general population or NOS)
Offspring of mothers without purchase of one or more selective serotonin reuptake inhibitor drugs. |
1st trimester | 441 / 618727 | Major malformations and cardiovascular malformations (excepted ASV, VSD and transpo of great vessels) updated in a larger study published by Furu 2015 (1996-2010). Thus only the not updated malformations are reported here. | |
| The Drug Reimbursement Register that contains data on 98% of reimbursed prescription drug purchases. | ||||||||
|
Marks (Controls exposed to Bupropion) 2021 |
USA 2010 - 2019 retrospective cohort |
Electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis, USA. | Pregnant women with one (or more) prescription of Escitalopram written during the time period studied. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women with one (or more) prescription of Bupropion written during the time period studied. |
during pregnancy (anytime or not specified) | 581 / 406 | '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy. | |
| Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis. | ||||||||
|
Marks (Controls unexposed, sick) 2021 |
USA 2010 - 2019 retrospective cohort |
Electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis, USA. | Pregnant women with one (or more) prescription of Esitalopram during the third trimester exposure. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women who took an antidepressant at some point during pregnancy but did not have a prescription for any antidepressant during the relevant period of exposure. |
3rd trimester | 283 / -9 | '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy. 'Neonatal intensive care unit admission" => not considered here because an exposure in early pregnancy could also lead to NICU admission. | |
| Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis. | ||||||||
|
Martin 2024 |
Norway, Sweden and United Kingdom. 1996 - 2020 population based cohort retrospective |
The UK’s Clinical Practice Research Datalink (CPRD), the Norway’s Medical Birth Registry and the Sweden’s Medical Birth Register. | Singleton deliveries with maternal Escitalopram (without concurrent prescriptions for different antidepressants) use during pregnancy proxied by prescriptions in the United Kingdom and dispensations in Norway and Sweden. |
unexposed (general population or NOS)
Singleton deliveries without maternal antidepressants use during pregnancy proxied by prescriptions in the United Kingdom and dispensations in Norway and Sweden. |
during pregnancy (anytime or not specified) | 15406 / 2408707 | A group ‘multiple’ (i.e drug switching or concurrent prescriptions for different antidepressants) is available => thus individual antidepressant considered as monotherapy. Unexposed numbers: Table S4. | |
| 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). | ||||||||
|
Merlob 2009 |
Israel 2000 - 2007 prospective cohort |
The Departments of Neonatology in Rabin Medical Center and Schneider Children’s Medical Center of Israel (affiliated with ENTIS). | Pregnant women who reported using Escitalopram during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who not reported using Selective serotonin reuptake inhibitors (SSRIs). |
1st trimester | 13 / 67636 | 'Any infant with multiple congenital anomalies or dysmorphic features underwent genetic evaluation by a trained expert to exclude a congenital syndrome.' | |
| 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. | ||||||||
|
Nordeng - Citalopram/Escitalopram (Controls unexposed, NOS) 2012 |
Norway 2000 - 2006 cohort |
The Norwegian Mother and Child Cohort Study (the MoBa study). | Exposure to Citalopram/Escitalopram during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
No reported use of any antidepressants in the 6 months before or during pregnancy. |
1st trimester | 243 / 61648 | Little overlapping between Nordeng 2012 (2000 - 2006) and Furu 2015 (including Norway 2005-10) => the 2 studies kept. | |
| The pregnant women completed 2 questionnaires during pregnancy at around gestational weeks 17 and 30, which included notably questions regarding medication use. | ||||||||
|
Nordeng - Citalopram/Escitalopram (Controls unexposed, sick) 2012 |
Norway 2000 - 2006 cohort |
The Norwegian Mother and Child Cohort Study (the MoBa study). | Exposure to Citalopram/Escitalopram during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies that reported use of an antidepressant during the 6 months before pregnancy, but not during pregnancy. |
1st trimester | 243 / 1048 | Little overlapping between Nordeng 2012 (2000 - 2006) and Furu 2015 (including Norway 2005-10) => the 2 studies kept. | |
| The pregnant women completed 2 questionnaires during pregnancy at around gestational weeks 17 and 30, which included notably questions regarding medication use. | ||||||||
|
Ozturk 2016 |
Turkey 2007 - 2012 prospective cohort |
An observational cohort study based on a prenatal consultation service. | Pregnant women exposed to Escitalopram during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women selected from the non-teratogen exposed pregnancies in the same year. |
at least 1st trimester | 35 / 275 | 'Drug exposures took place in 81% during the first trimester, and 11% in all three trimesters. Medical treatments were discontinued in most of recognized pregnancies.'=> considered as 'At least first trimester'. | |
| 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). | ||||||||
|
Palmsten (Controls exposed to TCA) 2013 |
USA 2000 - 2007 retrospective cohort (claims database) |
The US nationwide Medicaid Analytic eXtract (MAX). | Pregnant women with a depression diagnosis and a dispensation of Escitalopram in monotherapy during the exposure window. |
exposed to other treatment, sick
Pregnant women with a depression diagnosis and a dispensation of tricyclic antidepressant in monotherapy during the exposure window. |
2nd and/or 3rd trimester | 1936 / 441 | Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy. | |
| Outpatient pharmacy-dispensing data. | ||||||||
|
Palmsten (Controls unexposed, sick) 2013 |
USA 2000 - 2007 retrospective cohort (claims database) |
The US nationwide Medicaid Analytic eXtract (MAX). | Pregnant women with a depression diagnosis and a dispensation of escitalopram in monotherapy during the exposure window. |
unexposed, sick
Pregnant women with a depression diagnosis and no antidepressant exposure between the LMP and the end of the window. |
2nd and/or 3rd trimester | 1936 / 59219 | Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy. | |
| Outpatient pharmacy-dispensing data. | ||||||||
|
Palmsten b 2013 |
USA 2000 - 2007 retrospective cohort (claims database) |
The Medicaid Analytic eXtract (MAX) data | Women with a supply of Escitalopram monotherapy that overlapped with the delivery date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Women who had no supply of antidepressants in the five months before delivery. |
late pregnancy | 1022 / 69044 | Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery. | |
| Data of prescription. | ||||||||
|
Stephansson 2013 |
Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) 1996 - 2007 population based cohort retrospective |
A registry-based cohort study based on national registries of the 5 Nordic countries. | One or more filled prescriptions for Escitalopram from 3 months before the start of pregnancy until birth (different analysis according to period of exposure). |
unexposed (general population or NOS)
No prescriptions for an Selective serotonin reuptake inhibitors (SSRIs). |
3 months (or more) before pregnancy or during pregnancy | 3165 / 1604649 | Exclusion of pregnancies and births of mothers who had used other antidepressants with an effect on serotonin or norepinephrine activity (but not other antidepressants). Overlapping: Jimenez-Solem 2013 (not reported because included in Stephansson 2013). | |
| 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. | ||||||||
|
Viktorin - Citalopram or escitalopram (Controls unexposed, NOS) 2017 |
Sweden 2006 - 2014 population based cohort retrospective |
A birth cohort established by linkage of Swedish National registers. | Offspring that were born to mothers with at least 2 dispensations of citalopram or escitalopram overlapping the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Offspring that were born to mothers without any dispensation of an antidepressant with a medication period overlapping the pregnancy. |
during pregnancy (anytime or not specified) | 1097 / 172646 | ||
| Dispensations identified in the Swedish Prescribed Drug Register that holds information on all dispensed prescription drugs in Sweden. | ||||||||
|
Viktorin - Citalopram or escitalopram (Controls unexposed, sick) 2017 |
Sweden 2006 - 2014 population based cohort retrospective |
A birth cohort established by linkage of Swedish National registers. | Offspring that were born to mothers with a history of depression or anxiety with at least 2 dispensations of citalopram or escitalopram overlapping the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offspring that were born to mothers with a history of depression or anxiety without any dispensation of an antidepressant with a medication period overlapping the pregnancy. |
during pregnancy (anytime or not specified) | 639 / -9 | ||
| Dispensations identified in the Swedish Prescribed Drug Register that holds information on all dispensed prescription drugs in Sweden. | ||||||||
|
Yaris 2005 |
Turkey 1999 - 2004 prospective cohort |
Toxicology Information and Follow-up Service, Turkey | Women who were exposed to Escitalopram during pregnancy for depression, anxiety, and psychotic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Women who did not use any drug while pregnant. |
during pregnancy (anytime or not specified) | 1 / 248 | Multiple drug exposure. Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. | |
| Data surveyed by the interviews. | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Ames 2021 |
USA 2003 - 2011 case control |
The Study to Explore Early Development (SEED): a multisite case-control study of autism by the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) network. | Children with Autism spectrum disorder (ASD) or with other developmental delays or disorders (DDs) such as language delay or intellectual disability (ID) recruited from educational and clinical settings that serve children with developmental disorders. | Children from the general population randomly sampled state birth records at each study site who either scored <11 on the SCQ or scored >=11 but did not meet ASD criteria after the in-person assessment. | 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. | 3 months (or more) before pregnancy or during pregnancy | 1750 / 1671 | The final analytic sample comprised 1367 children with ASD, 1750 with DDs, and 1671 POP controls. No age specified in article but in CDC website: 'The study will include children with ASD, with other DDs, and with typical development, ages 2-5 years'. | |
| 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. | |||||||||
|
Anderson 2020 |
USA 1997 - 2011 case control |
The National Birth Defects Prevention Study (NBDPS), a US population-based, multisite case-control study. | The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. | The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. | 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. | 1st trimester | 30630 / 11478 | Overlapping: this study is an update of Alwan 2007. 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.' | |
| 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. | |||||||||
|
Dave 2019 |
USA 2011 - 2015 nested case control |
The IBM MarketScan commercial claims database, an employer- sourced health insurance database. | Neonatal abstinence syndrome (NAS) in live births. | No neonatal abstinence syndrome (NAS) in live births. | The IBM MarketScan commercial claims database, an employer- sourced health insurance database. | 3rd trimester | 659 / 621281 | ||
| 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. | |||||||||
|
Kitchin 2022 |
Spain 2002 - 2015 case control |
The Spanish database BIFAP (Base de Datos para la Investigacion Farmacoepidemiologica en Atencion Primaria, Database for Pharmacoepidemiological Research in Primary Care) | Pregnant woman suffering a miscarriage. | Pregnant woman randomly selected from the whole cohort among women who were still at risk within follow-up, by risk-set sampling and individually matched to cases. | 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. | 1st trimester | 18070 / 54209 | ||
| 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. | |||||||||
|
Laspro 2024 |
USA 2013 - 2023 nested case control |
EPIC Cosmos, a database incorporating health information of 180 million patients, throughout the United States from approximately 180 US institutions utilizing EPIC medical records. | Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37). | Newborns without oral clefts. | Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy. | during pregnancy (anytime or not specified) | 12098 / -9 | P-values were calculated, while to account for multiple testing (693 hypotheses) Benjamini- Hochberg (BH) corrections were performed with a false discovery rate (Q) of 0.05. | |
| Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records. | |||||||||
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Wemakor 2015 |
Belgium, Spain, Ireland, Malta, Netherlands, Norway, Denmark, FR, Germany, Italy, Switzerland, UK 1995 - 2009 case control |
Case-malformed control study based on 12 population-based European Surveillance of Congenital Anomalies (EUROCAT) congenital anomaly registries. | Babies with congenital heart defects (CHD) or with congenital anomalies other than CHD identified as significantly associated with SSRI exposure (‘‘signals’’) in at least one previous study. | All other registrations. | 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). | 1st trimester | 12876 / 17083 | 'Women were excluded if they took non-SSRI antidepressants or unspecified antidepressants and for the specific SSRI analyses, if they took more than one specific SSRI'. '12,876 with CHD, 13,024 with one or more of the 15 ‘signal’ subgroups'. | |
| 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. | |||||||||
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Yazdy 2014 |
USA 2006 - 2011 case control |
The Slone epidemiology center at Boston University, a population-based case-control study, based on registries in Massachusetts, north carolina, and new York. | Infants with a diagnosis of talipes equinovarus ('clubfoot') without a known syndrome. | Infants with no major malformations or foot problems, drawn from the same birth population as cases and selected from either birth certificates (Massachusetts and north carolina) or hospital medical records (new York). | 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. | 1st trimester | 622 / 2002 | ||
| 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%). | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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