Sertraline 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.
S7468
R22194
Anderson, 2020 Omphalocele 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.06 [0.43;2.61] -/-   0/- - -
ref
S8217
R25653
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 1.99 [0.12;32.10] C
excluded (exposition period)
0/1,374   92/506,155 92 1,374
ref
S5398
R14862
Bérard (Controls exposed to non-Sertraline SSRI), 2015 Omphalocele 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.07 [0.05;22.39] C
excluded (control group)
0/366   2/1,963 2 366
ref
S6705
R18934
Bérard (Controls unexposed, sick), 2015 Omphalocele 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.31 [0.08;21.95] C 0/366   15/14,868 15 366
ref
S6159
R16150
Louik, 2007 Omphalocele 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 5.70 [1.60;20.70] 3/49   124/5,938 127 49
ref
Total 3 studies 2.07 [0.59;7.21] 142 415
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 1.06[0.43; 2.61]--47%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: unclearROB reporting: moderate Bérard (Controls unexposed, sick), 2015Bérard, 2015 1 1.31[0.08; 21.95]1536615%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Louik, 2007Louik, 2007 5.70[1.60; 20.70]1274938%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (3 studies) I2 = 55% 2.07[0.59; 7.21]1424150.520.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.31[0.08; 21.95]15366 -NABérard (Controls unexposed, sick), 2015 1 case control studiescase control studies 2.31[0.45; 11.93]1274977%NAAnderson, 2020 Louik, 2007 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.31[0.45; 11.93]1274977%NAAnderson, 2020 Louik, 2007 2 unexposed, sickunexposed, sick 1.31[0.08; 21.95]15366 -NABérard (Controls unexposed, sick), 2015 1 Tags Adjustment   - No  - No 1.31[0.08; 21.95]15366 -NABérard (Controls unexposed, sick), 2015 1   - Yes  - Yes 2.31[0.45; 11.93]1274977%NAAnderson, 2020 Louik, 2007 2 Monotherapy   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.08[0.46; 2.55]153660%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 5.70[1.58; 20.50]12749 -NALouik, 2007 1 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.31[0.08; 21.95]15366 -NABérard (Controls unexposed, sick), 2015 1 All studiesAll studies 2.07[0.59; 7.21]14241555%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 Louik, 2007 30.520.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 5398

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.31[0.45; 11.93]1274977%NAAnderson, 2020 Louik, 2007 2 unexposed, sick controlsunexposed, sick controls 1.31[0.08; 21.95]15366 -NABérard (Controls unexposed, sick), 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.07[0.05; 22.39]2366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Reefhuis (Omphalocele)Reefhuis (Omphalocele) 1.40[0.70; 2.80]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT3 metaPregmetaPreg 2.07[0.59; 7.21]55%415----Anderson, 2020 Bérard (Controls unexposed, sick), 2015 Louik, 2007 30.510.01.0