Omeprazole updated on 08-08-2023

Major congenital malformations

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S18810
R80039		 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 1.05 [0.91;1.21]
excluded (control group) 		228/5,751   17,219/476,733 17,447 5,751
ref
S18814
R80043		 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 0.90 [0.74;1.09] 228/5,751   262/5,955 490 5,751
ref
S4447
R10561		 Matok, 2012 Major malformations (according to CDC definitions) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.11 [0.87;1.43] 67/955   6,438/109,828 6,505 955
ref
S4669
R11466		 Bànhidy, 2011 Congenital abnormalities during pregnancy (anytime or not specified) excluded case control unexposed (general population or NOS) Adjustment: No Matched 1.23 [1.02;1.47] C
excluded (exposition period) 		206/487   22,637/60,507 22,843 487
ref
S4408
R10434		 Pasternak, 2010 Major birth defects (Exposure during First Trimester) 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.05 [0.79;1.40] 52/1,800   21,867/837,317 21,919 1,800
ref
S4517
R10872		 Diav-Citrin, 2005 Major anomalies 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No 1.09 [0.49;2.42] C 8/194   30/792 38 194
ref
S8548
R28404		 Moretti, 2001 Major malformations at least 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No 1.36 [0.20;9.38] 2/55   2/75 4 55
ref
S4591
R11079		 Lalkin (Controls exposed to other treatment, sick), 1998 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No Matched 1.71 [0.37;7.89] C
excluded (control group) 		4/78   3/98 7 78
ref
S4594
R11094		 Lalkin (Controls unexposed NOS), 1998 Major malformations 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Matched 1.73 [0.31;9.76] C 4/78   2/66 6 78
ref
Total 6 studies 1.00 [0.87;1.14] 28,962 8,833
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

StudyTE95% CIn casesn exposedweightROBABCDEF Broe (Controls unexposed, sick), 2025Broe, 2025 1 0.90[0.74; 1.09]4905,75147%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Matok, 2012Matok, 2012 1.11[0.87; 1.43]6,50595528%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Pasternak, 2010Pasternak, 2010 1.05[0.79; 1.40]21,9191,80021%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Diav-Citrin, 2005Diav-Citrin, 2005 1.09[0.49; 2.42]381943%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Moretti, 2001Moretti, 2001 1.36[0.20; 9.38]4550%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Lalkin (Controls unexposed NOS), 1998Lalkin, 1998 2 1.73[0.31; 9.76]6781%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (6 studies) I2 = 0% 1.00[0.87; 1.14]28,9628,8330.25.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.00[0.87; 1.14]28,9628,8330%NABroe (Controls unexposed, sick), 2025 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 Moretti, 2001 Lalkin (Controls unexposed NOS), 1998 6 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.09[0.91; 1.31]28,4723,0820%NAMatok, 2012 Pasternak, 2010 Diav-Citrin, 2005 Moretti, 2001 Lalkin (Controls unexposed NOS), 1998 5 unexposed, sickunexposed, sick 0.90[0.74; 1.09]4905,751 -NABroe (Controls unexposed, sick), 2025 1 Tags Adjustment   - No  - No 1.20[0.61; 2.37]483270%NADiav-Citrin, 2005 Moretti, 2001 Lalkin (Controls unexposed NOS), 1998 3   - Yes  - Yes 0.99[0.87; 1.13]28,9148,5060%NABroe (Controls unexposed, sick), 2025 Matok, 2012 Pasternak, 2010 3 MatchedMatched 1.73[0.31; 9.76]678 -NALalkin (Controls unexposed NOS), 1998 1 All studiesAll studies 1.00[0.87; 1.14]28,9628,8330%NABroe (Controls unexposed, sick), 2025 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 Moretti, 2001 Lalkin (Controls unexposed NOS), 1998 60.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.32.31.1780.000Broe (Controls unexposed, sick), 2025Matok, 2012Pasternak, 2010Diav-Citrin, 2005Moretti, 2001Lalkin (Controls unexposed NOS), 1998

Asymetry test p-value = 0.2269 (by Egger's regression)

slope=-0.0872 (0.0736); intercept=0.6355 (0.4455); t=1.4263; p=0.2269

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 4591, 18810

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.07[0.95; 1.19]45,9198,8330%NABroe (Controls unexposed, general pop), 2025 Matok, 2012 Pasternak, 2010 Diav-Citrin, 2005 Moretti, 2001 Lalkin (Controls unexposed NOS), 1998 6 unexposed, sick controlsunexposed, sick controls 0.90[0.74; 1.09]4905,751 -NABroe (Controls unexposed, sick), 2025 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.71[0.37; 7.89]778 -NALalkin (Controls exposed to other treatment, sick), 1998 10.510.01.0