| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Andersen, 2014 |
Denmark 1997 - 2010 |
All pregnancies in Denmark during the study period. | 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. |
2377 / 1256956 | |
| Ban (Controls unexposed, disease free), 2014 |
United Kingdom 1990 - 2009 |
All singleton live births for women aged 15– 45years in which the medical records of the mothers and the children were linked to provide prospectively recorded information throughout pregnancy and in the year before pregnancy. | Pregnant women with 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. |
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. |
| Ban (Controls unexposed, sick), 2014 |
United Kingdom 1990 - 2009 |
All singleton live births for women aged 15– 45years in which the medical records of the mothers and the children were linked to provide prospectively recorded information throughout pregnancy and in the year before pregnancy. | Pregnant women with 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. |
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. |
| Chan (Controls exposed to TCA), 2024 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018. | Infants of women 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. |
47 / 322 | |
| Chan (Controls unexposed, pop general), 2024 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018. | Infants of women with prescription of 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. |
47 / 462377 | |
| Colvin, 2012 |
Australia 2002 - 2005 |
All births in Western Australia during the study period. | 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. |
-9 / 94561 | Nb of exposed children not reported. |
| Cornet, 2024 |
USA 2011 - 2019 |
Infants born at ≥37 weeks’ gestational age at 15 Kaiser Permanente Northern California (KPNC) hospitals between 1 November 2011 and 31 July 2019, whose mothers received prenatal care in KPNC. | Infants with any maternal 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. |
382 / 272517 | Dose-dependent relationship of individuals substances: no conclusion provided by authors. |
| Einarson, 2009 |
Canada Not specified. |
Women call the service for information regarding the safety of a drug. | 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. |
21 / 928 | |
| Furu, 2015 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2010 |
Women who gave birth to a live singleton infant during the study period (different periods according to country). | Infants born to women who filled a prescription for 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. |
3950 / 2266875 | |
| Heuvelman, 2023 |
United Kingdom 1995 - 2017 |
Pregnancies in Clinical Practice Research Datalink (CPRD) with a history of depressive symptoms or use of antidepressants in the preceding year before pregnancy. | Women who had initiated or continued Escitalopram for the treatment of depressive symptoms during pregnancy. |
unexposed, sick
Women who did not initiate or who discontinue antidepressants during pregnancy. |
546 / 16330 | Dose–response relationships, sibling design and negative control for antidepressants use as a whole (not for the class of antidepressants). |
| Jimenez-Solem (Controls unexposed, NOS), 2012 |
Denmark 1997 - 2009 |
Pregnant women in Denmark and their offspring during the study period (all live births). | Pregnancies with a continuous exposure to 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. |
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. |
| Jimenez-Solem (Controls unexposed, sick), 2012 |
Denmark 1997 - 2009 |
Pregnant women in Denmark and their offspring during the study period (all live births). | Pregnancies with a continuous exposure to 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). |
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. |
| Jordan, 2016 |
Norway, Wales and Denmark. 2000 - 2010 |
All foetuses (live or still born or termination of pregnancy) and infants who 1) would have appeared in the EUROCAT registries had they been diagnosed with a major congenital anomaly, 2) had linked maternal prescription data. | Prescription of 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. |
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. |
| Källén, 2007 |
Sweden 1995 - 2004 |
Nearly all deliveries in Sweden during the study period. | 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. |
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). |
| Kieler, 2012 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2007 |
All singletons born after 231 gestational days (33 weeks). | 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. |
3247 / 1588140 | |
| Klieger-Grossmann, 2012 |
Canada, Switzerland and Italy Not specified. |
Women who call centers for information regarding the safety of a drug, usually early in pregnancy. | Pregnant women exposed to escitalopram during pregnancy. |
unexposed (general population or NOS)
Pregnant women who called for nonteratogenic exposures such as acetaminophen, antibiotics, anti- histamines, and so on. |
213 / 212 | The 21 exposures to escitalopram that were part of a larger prospective study from Motherisk (Einarson 2009) were excluded from this study. Results versus other antidepressants (SSRIs, venlafaxine, mirtazapine...) not reported => inadequate control group. |
| Kolding (Controls unexposed, disease free) , 2021 |
Denmark 2007 - 2014 |
All clinically recognized singleton pregnancies with fetuses alive at the nuchal scan from 11 completed gestational weeks. | Pregnant women with two or more redeemed prescriptions of 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. |
308 / 353581 | 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.' |
| Kolding (Controls unexposed, sick), 2021 |
Denmark 2007 - 2014 |
All clinically recognized singleton pregnancies with fetuses alive at the nuchal scan from 11 completed gestational weeks. | Pregnant women with two or more redeemed prescriptions of 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). |
308 / 6326 | 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.' |
| Lee (Controls exposed to TCAs), 2025 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals in Hong Kong between January 1, 2003 and December 31, 2018. | Women filling at least one prescription of 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. |
71 / 613 | |
| Lee (Controls unexposed, general pop), 2025 |
China 2003 - 2018 |
All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals in Hong Kong between January 1, 2003 and December 31, 2018. | Women filling at least one prescription of 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. |
71 / 463440 | |
| Liu, 2017 |
Denmark 1998 - 2012 |
All liveborn singletons during the study period. | 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). |
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. |
| Malm, 2011 |
Finland 1996 - 2006 |
All the Finnish births and terminations attributable to severe fetal anomalies during the study period. | Offspring of mothers with at least one purchase of 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. |
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. |
| Marks (Controls exposed to Bupropion), 2021 |
USA 2010 - 2019 |
Women who received at least one antidepressant prescription 3 months prior to conception through delivery. | Pregnant women with one (or more) prescription of 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. |
581 / 406 | '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy. |
| Marks (Controls unexposed, sick), 2021 |
USA 2010 - 2019 |
Women who received at least one antidepressant prescription 3 months prior to conception through delivery. | Pregnant women with one (or more) prescription of 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. |
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. |
| Martin, 2024 |
Norway, Sweden and United Kingdom. 1996 - 2020 |
Singleton deliveries 22 weeks’ completed gestational weeks registered in the different databases during the study periods (UK: 1996-2018, Norway: 2009-2020, Sweden: 2006-2020). | Singleton deliveries with maternal 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. |
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. |
| Merlob, 2009 |
Israel 2000 - 2007 |
Pregnant women who gave birth at the tertiary center | 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). |
13 / 67636 | 'Any infant with multiple congenital anomalies or dysmorphic features underwent genetic evaluation by a trained expert to exclude a congenital syndrome.' |
| Nordeng - Citalopram/Escitalopram (Controls unexposed, NOS), 2012 |
Norway 2000 - 2006 |
All women who gave birth in Norway, recruited into at the routine ultrasound examination in gestational weeks 17 to 18. Multiple births as well as infants with chromosomal abnormalities were excluded from the analyses. | Exposure to 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. |
243 / 61648 | Little overlapping between Nordeng 2012 (2000 - 2006) and Furu 2015 (including Norway 2005-10) => the 2 studies kept. |
| Nordeng - Citalopram/Escitalopram (Controls unexposed, sick), 2012 |
Norway 2000 - 2006 |
All women who gave birth in Norway, recruited into at the routine ultrasound examination in gestational weeks 17 to 18. Multiple births as well as infants with chromosomal abnormalities were excluded from the analyses. | Exposure to 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. |
243 / 1048 | Little overlapping between Nordeng 2012 (2000 - 2006) and Furu 2015 (including Norway 2005-10) => the 2 studies kept. |
| Ozturk, 2016 |
Turkey 2007 - 2012 |
Pregnant women referred to the prenatal consultation service for psychotropic drug exposure. | Pregnant women exposed to Escitalopram during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women selected from the non-teratogen exposed pregnancies in the same year. |
35 / 275 | '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'. |
| Palmsten (Controls exposed to TCA), 2013 |
USA 2000 - 2007 |
Pregnant women with a depression diagnosis enrolled in Medicaid. | Pregnant women with a depression diagnosis and a dispensation of 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. |
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. |
| Palmsten (Controls unexposed, sick), 2013 |
USA 2000 - 2007 |
Pregnant women with a depression diagnosis enrolled in Medicaid. | Pregnant women with a depression diagnosis and a dispensation of 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. |
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. |
| Palmsten b, 2013 |
USA 2000 - 2007 |
Subcohort of pregnancies in women with diagnoses for mood or anxiety disorders (between one and five months before delivery), ending in live birth among women aged 12-55. | Women with a supply of 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. |
1022 / 69044 | Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery. |
| Stephansson, 2013 |
Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) 1996 - 2007 |
All singletons born after 154 gestational days during the study period. | One or more filled prescriptions for 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). |
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). |
| Viktorin - Citalopram or escitalopram (Controls unexposed, NOS), 2017 |
Sweden 2006 - 2014 |
All live-born children conceived from July 1, 2005 and born in 2006 and 2007. | Offspring that were born to mothers with at least 2 dispensations of 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. |
1097 / 172646 | |
| Viktorin - Citalopram or escitalopram (Controls unexposed, sick), 2017 |
Sweden 2006 - 2014 |
All live-born children conceived from July 1, 2005 and born in 2006 and 2007. | Offspring that were born to mothers with 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. |
639 / -9 | |
| Yaris, 2005 |
Turkey 1999 - 2004 |
Pregnant women calling for a counseling about the teratogenic risks of drugs, chemicals, and X-ray. | Women who were exposed to 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. |
1 / 248 | Multiple drug exposure. Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|---|---|---|---|---|
| Ames, 2021 |
USA 2003 - 2011 |
Children with Autism spectrum disorder (ASD) or with other developmental delays or disorders (DDs) such as language delay or intellectual disability (ID) recruited from educational and clinical settings that serve children with developmental disorders. | Children from the general population randomly sampled state birth records at each study site who either scored <11 on the SCQ or scored >=11 but did not meet ASD criteria after the in-person assessment. | 1750 / 1671 | The final analytic sample comprised 1367 children with ASD, 1750 with DDs, and 1671 POP controls. No age specified in article but in CDC website: 'The study will include children with ASD, with other DDs, and with typical development, ages 2-5 years'. |
| Anderson, 2020 |
USA 1997 - 2011 |
The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. | The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. | 30630 / 11478 | Overlapping: this study is an update of Alwan 2007. 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.' |
| Dave, 2019 |
USA 2011 - 2015 |
Neonatal abstinence syndrome (NAS) in live births. | No neonatal abstinence syndrome (NAS) in live births. | 659 / 621281 | |
| Kitchin, 2022 |
Spain 2002 - 2015 |
Pregnant woman suffering a miscarriage. | Pregnant woman randomly selected from the whole cohort among women who were still at risk within follow-up, by risk-set sampling and individually matched to cases. | 18070 / 54209 | |
| Laspro, 2024 |
USA 2013 - 2023 |
Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37). | Newborns without oral clefts. | 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. |
| Wemakor, 2015 |
Belgium, Spain, Ireland, Malta, Netherlands, Norway, Denmark, FR, Germany, Italy, Switzerland, UK 1995 - 2009 |
Babies with congenital heart defects (CHD) or with congenital anomalies other than CHD identified as significantly associated with SSRI exposure (‘‘signals’’) in at least one previous study. | All other registrations. | 12876 / 17083 | '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'. |
| Yazdy, 2014 |
USA 2006 - 2011 |
Infants with a diagnosis of talipes equinovarus ('clubfoot') without a known syndrome. | Infants with no major malformations or foot problems, drawn from the same birth population as cases and selected from either birth certificates (Massachusetts and north carolina) or hospital medical records (new York). | 622 / 2002 |
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