Esomeprazole updated on 08-08-2023

All congenital malformations (majors, minors, majors and minors, or unspecified)

id	Study   Auto Broe (Controls unexposed, general pop), 2025Broe (Controls unexposed, sick), 2025Choi a, 2023Pasternak, 2010	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.
S18813 R80050	Broe (Controls unexposed, general pop), 2025	Major congenital malformations (exclusion of chromosomal abnormalities (ICD-10 codes Q90– Q99))	1st trimester	population based cohort retrospective	unexposed (general population or NOS) excluded	Adjustment: Yes	1.47 [1.10;1.95] excluded (control group)	52/1,104   17,374/481,595	17,426	1,104		ref
S18817 R80051	Broe (Controls unexposed, sick), 2025	Major congenital malformations (exclusion of chromosomal abnormalities (ICD-10 codes Q90– Q99))	1st trimester	population based cohort retrospective	unexposed, sick	Adjustment: Yes	1.07 [0.75;1.52]	52/1,104   127/2,773	179	1,104		ref
S14455 R57401	Choi a, 2023	Major congenital malformations	1st trimester	retrospective cohort (claims database)	unexposed, sick	Adjustment: Yes	1.10 [1.02;1.20]	542/12,516   85,900/2,655,676	86,442	12,516		ref
S4412 R28450	Pasternak, 2010	Major birth defects (Exposure during First Trimester)	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes	1.19 [0.77;1.84]	23/668   21,867/837,317	21,890	668		ref
					Total	3 studies	1.10 [1.02;1.19]		108,511	14,288
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 18813