Nortriptyline - Medication and Pregnancy KB

Nortriptyline

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Kjaersgaard (Controls unexposed, NOS), 2013	Denmark 1997 - 2008	All clinically recognized pregnancies in Denmark with an estimated conception and an observed pregnancy outcome during the study period.	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.	-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 (Controls unexposed, sick), 2013	Denmark 1997 - 2008	All clinically recognized pregnancies in Denmark with an estimated conception and an observed pregnancy outcome during the study period.	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.	-9 / -9	Molar or ectopic pregnancies (ICD-10: O00.0– O01.9) were excluded from the main analyses.
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 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.	172 / 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 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).	172 / 6326	'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.'
Lee (Controls exposed to SSRI), 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 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.	117 / 1465
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 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.	117 / 463440

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
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	'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.

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