| 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 |
|---|---|---|---|---|---|---|---|---|
|
Kjaersgaard (Controls unexposed, NOS) 2013 |
Denmark 1997 - 2008 population based cohort retrospective |
Danish administrative health registries. | Mother that had redeemed a prescription for Nortriptyline 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 Nortriptyline 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. | ||||||||
|
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 Nortriptyline 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 | 172 / 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 Nortriptyline 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 | 172 / 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 SSRI) 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 Nortriptyline 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 selective serotonin reuptake inhibitors (SSRI) 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) | 117 / 1465 | ||
| 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 Nortriptyline 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) | 117 / 463440 | ||
| The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing 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 |
|---|---|---|---|---|---|---|---|---|---|
|
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.'. Mistake in table 1 for the nb of exposed control: 3 was chosen rather than 8, to have to right sum of exposures. | |
| 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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