Imipramine - Medication and Pregnancy KB

Imipramine

Exposed non-exposed, cohort studies

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 2013	Denmark 1997 - 2008 population based cohort retrospective	Danish administrative health registries.	Mother that had redeemed a prescription for Imipramine 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.
Kjaersgaard 2013	Denmark 1997 - 2008 population based cohort retrospective	Danish administrative health registries.	Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics.		during pregnancy (anytime or not specified)	-9 / 983258
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 Imipramine 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)	64 / 1465
Lee (Controls exposed to SSRI) 2025	China 2003 - 2018 retrospective cohort (claims database)		The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records.		during pregnancy (anytime or not specified)	64 / 1465
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 Imipramine 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)	64 / 463440
Lee (Controls unexposed, general pop) 2025	China 2003 - 2018 retrospective cohort (claims database)		The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records.		during pregnancy (anytime or not specified)	64 / 463440

Case-control studies

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.'
Anderson 2020	USA 1997 - 2011 case control		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.			1st trimester	30630 / 11478
Kullander 1976	Sweden 1963 - 1965 nested case control	The Department of Gynecology and Obstetrics and the Department of Embryology, University of Lund, Sweden.	Infants with different kinds of malformations.	Infants without malformations.	Information on drug use was obtained mainly from the questionnaires administered to pregnant women, sometimes supplemented from hospital records etc. Information was usually collected before the outcome of the pregnancy was known. The (approximate) time of intake of each drug used was recorded.	1st trimester	751 / 5002
Kullander 1976	Sweden 1963 - 1965 nested case control		All living children were carefully investigated by a pediatrician after birth and were followed to about 1 year old at the child health centres. Autopsy was performed and the age at death was recorded. The presence of major and minor malformations was recorded for all infants.			1st trimester	751 / 5002

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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