Selective Serotonin Reuptake Inhibitor (SSRI) updated on 07-01-2025

Omphalocele

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.
S7467
R22136		 Anderson, 2020 Omphalocele 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: SSRI only 0.94 [0.52;1.69] -/-   0/- - -
ref
S5372
R18263		 Jordan, 2016 Omphalocele 3 months or more before pregnancy or1st trimester excluded retrospective cohort (registry) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 1.27 [0.40;4.02] C
excluded (exposition period) 		3/12,962   92/506,155 95 12,962
ref
S6704
R18919		 Bérard - Non Sertraline SSRI, 2015 Omphalocele 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: No Monotherapy: SSRI only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.01 [0.23;4.42] C 2/1,963   15/14,868 17 1,963
ref
S516
R15361		 Furu (Controls unexposed, NOS), 2015 Omphalocele 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: SSRI only 2.11 [1.01;4.39] 10/36,772   270/2,266,875 280 36,772
ref
S497
R16475		 Malm, 2011 Omphalocele 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.47 [0.11;1.94] -/6,976   -/628,607 - 6,976
ref
S5424
R16094		 Louik, 2007 Omphalocele 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.40 [0.40;4.50] 3/163   124/5,824 127 163
ref
Total 5 studies 1.18 [0.75;1.85] 424 45,874
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 Anderson, 2020Anderson, 2020 0.94[0.52; 1.69]--40%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Bérard - Non Sertraline SSRI, 2015Bérard - Non Sertraline SSRI, 2015 1.01[0.23; 4.42]171,9639%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Furu (Controls unexposed, NOS), 2015Furu, 2015 1 2.11[1.01; 4.39]28036,77229%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 0.47[0.11; 1.94]-6,9769%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Louik, 2007Louik, 2007 1.40[0.40; 4.50]12716313%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (5 studies) I2 = 14% 1.18[0.75; 1.85]42445,8740.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.19[0.48; 2.96]29745,71144%NABérard - Non Sertraline SSRI, 2015 Furu (Controls unexposed, NOS), 2015 Malm, 2011 3 case control studiescase control studies 1.01[0.60; 1.72]1271630%NAAnderson, 2020 Louik, 2007 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.19[0.68; 2.07]40743,91135%NAAnderson, 2020 Furu (Controls unexposed, NOS), 2015 Malm, 2011 Louik, 2007 4 unexposed, sickunexposed, sick 1.01[0.23; 4.42]171,963 -NABérard - Non Sertraline SSRI, 2015 1 Tags Adjustment   - No  - No 1.01[0.23; 4.42]171,963 -NABérard - Non Sertraline SSRI, 2015 1   - Yes  - Yes 1.19[0.68; 2.07]40743,91135%NAAnderson, 2020 Furu (Controls unexposed, NOS), 2015 Malm, 2011 Louik, 2007 4 Monotherapy   - no or not specified  - no or not specified 0.87[0.30; 2.51]1277,13923%NAMalm, 2011 Louik, 2007 2   - SSRI only  - SSRI only 1.29[0.73; 2.29]29738,73532%NAAnderson, 2020 Bérard - Non Sertraline SSRI, 2015 Furu (Controls unexposed, NOS), 2015 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.01[0.23; 4.42]171,963 -NABérard - Non Sertraline SSRI, 2015 1 All studiesAll studies 1.18[0.75; 1.85]42445,87414%NAAnderson, 2020 Bérard - Non Sertraline SSRI, 2015 Furu (Controls unexposed, NOS), 2015 Malm, 2011 Louik, 2007 50.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.81.90.9040.000Anderson, 2020Bérard - Non Sertraline SSRI, 2015Furu (Controls unexposed, NOS), 2015Malm, 2011Louik, 2007

Asymetry test p-value = 0.6925 (by Egger's regression)

slope=0.4444 (0.6786); intercept=-0.6534 (1.4999); t=0.4356; p=0.6925

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.19[0.68; 2.07]40743,91135%NAAnderson, 2020 Furu (Controls unexposed, NOS), 2015 Malm, 2011 Louik, 2007 4 unexposed, sick controlsunexposed, sick controls 1.01[0.23; 4.42]171,963 -NABérard - Non Sertraline SSRI, 2015 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Gao - SSRI (Omphalocele)Gao - SSRI (Omphalocele) 1.73[1.03; 2.89]-U,GPunexposed (general population or NOS)T11st trimesterstudies TTT3 metaPregmetaPreg 1.18[0.75; 1.85]14%45,874----Anderson, 2020 Bérard - Non Sertraline SSRI, 2015 Furu (Controls unexposed, NOS), 2015 Malm, 2011 Louik, 2007 50.510.01.0