| 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 |
|---|---|---|---|---|---|---|---|---|
|
Källen 2013 |
Sweden 1996 - 2011 population based cohort retrospective |
Swedish Medical Birth Register | Infants whose mothers used Clomipramine in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy. |
early pregnancy | 1391 / 1575847 | This publication largely included data of Kallen 2003 (cardiac malformations - study period 1995-2001). | |
| The exposure data are either based on midwife interviews from the first antenatal visit (usually during weeks 10–12) or on linkage with a prescribed drug register. | ||||||||
|
Kjaersgaard (Controls unexposed, NOS) 2013 |
Denmark 1997 - 2008 population based cohort retrospective |
Danish administrative health registries. | Mother that had redeemed a prescription for Clomipramine at any time from 30 days before conception up to 1 day before the end of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Mother that had not redeemed any prescription for antidepressant medication from 6 months before conception up to 1 day before the end of the pregnancy. |
during pregnancy (anytime or not specified) | -9 / 983258 | Molar or ectopic pregnancies (ICD-10: O00.0– O01.9) were excluded from the main analyses. Unexposed cohort: 1843 plus 981415 = 983258. | |
| Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics. | ||||||||
|
Kjaersgaard (Controls unexposed, sick) 2013 |
Denmark 1997 - 2008 population based cohort retrospective |
Danish administrative health registries. | Mother with a registry-based diagnosis of depressive disorder that had redeemed a prescription for Clomipramine at any time from 30 days before conception up to 1 day before the end of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Mother with a registry-based diagnosis of depressive disorder that had not redeemed any prescription for antidepressant medication from 6 months before conception up to 1 day before the end of the pregnancy. |
during pregnancy (anytime or not specified) | -9 / -9 | Molar or ectopic pregnancies (ICD-10: O00.0– O01.9) were excluded from the main analyses. | |
| Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics. | ||||||||
|
Ozturk 2016 |
Turkey 2007 - 2012 prospective cohort |
An observational cohort study based on a prenatal consultation service. | Pregnant women exposed to Clomipramine 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 | 1 / 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). | ||||||||
|
Rai (Controls exposed to SSRIs) 2017 |
Sweden 2001 - 2011 prospective cohort |
The Stockholm youth cohort, an observational prospective cohort study of Stockholm County. | Children of mothers who used Clomipramine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children of mothers who used Selective serotonin reuptake inhibitors (SSRIs) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
during pregnancy (anytime or not specified) | 235 / 2710 | Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy. | |
| 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). | ||||||||
|
Rai (Controls unexposed, disease free) 2017 |
Sweden 2001 - 2011 prospective cohort |
The Stockholm youth cohort, an observational prospective cohort study of Stockholm County. | Children of mothers who used Clomipramine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
No maternal psychiatric disorder and unexposed to antidepressants |
during pregnancy (anytime or not specified) | 235 / 238943 | Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy. | |
| 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). | ||||||||
|
Rai (Controls unexposed, sick) 2017 |
Sweden 2001 - 2011 prospective cohort |
The Stockholm youth cohort, an observational prospective cohort study of Stockholm County. | Children of mothers who used Clomipramine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of mothers with psychiatric disorders (any time before the birth of the child) who did not take antidepressants during pregnancy. |
during pregnancy (anytime or not specified) | 235 / 12325 | Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy. | |
| 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). | ||||||||
|
Yaris 2005 |
Turkey 1999 - 2004 prospective cohort |
Toxicology Information and Follow-up Service | Women who were exposed to Clomipramine 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) | 13 / 248 | Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. Raw data for premature delivery not reported because the denominator is 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 |
|---|---|---|---|---|---|---|---|---|---|
|
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 TCAs 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 estimated date of delivery (EDD). | 1st trimester | 30630 / 11478 | '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. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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