Sertraline updated on 07-01-2025

Genital anomalies

id	Study   Auto Bérard (Controls exposed to non-Sertraline SSRI), 2015Bérard (Controls unexposed, sick), 2015Ban (Controls unexposed, disease free), 2014Ban (Controls unexposed, sick), 2014Jimenez-Solem (Controls unexposed, NOS), 2012Jimenez-Solem (Controls unexposed, sick), 2012	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimesterPaternal exp. genotoxic window only (0–3 months preconception)Paternal exposure: epigenetic window only (3–xxx months preconception)Paternal exposure: genotoxic/epigenetic window (0–xxx months preconception)Paternal exposure: other window	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S5398 R14857	Bérard (Controls exposed to non-Sertraline SSRI), 2015	Genital organs malformations	1st trimester	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	1.19 [0.40;3.55] C excluded (control group)	4/366   18/1,963	22	366		ref
S6705 R18929	Bérard (Controls unexposed, sick), 2015	Genital organs malformations	1st trimester	retrospective cohort (claims database)	unexposed, sick	Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy)	0.97 [0.34;2.75]	4/366   160/14,868	164	366		ref
S5888 R14766	Ban (Controls unexposed, disease free), 2014	Genital system malformations	1st trimester	retrospective cohort (claims database)	unexposed, disease free excluded	Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...)	0.32 [0.04;2.40] excluded (control group)	-/757   1,292/325,294	-	757		ref
S5889 R14781	Ban (Controls unexposed, sick), 2014	Genital system malformations	1st trimester	retrospective cohort (claims database)	unexposed, sick	Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy)	0.26 [0.04;1.87]	-/757   67/13,432	-	757		ref
S6018 R15578	Jimenez-Solem (Controls unexposed, NOS), 2012	Congenital malformations of the external genital organs	1st trimester	population based cohort retrospective	unexposed (general population or NOS) excluded	Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...)	0.41 [0.06;2.93] excluded (control group)	1/817   2,504/843,797	2,505	817		ref
S6023 R15631	Jimenez-Solem (Controls unexposed, sick), 2012	Congenital malformations of the external genital organs	1st trimester	population based cohort retrospective	unexposed, sick	Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy)	0.49 [0.04;5.44] C	1/817   2/806	3	817		ref
					Total	3 studies	0.68 [0.29;1.61]		167	1,940
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 6018, 5888, 5398