Sertraline updated on 07-01-2025

Urinary 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.
S8217
R25654		 Jordan, 2016 Urinary 3 months or more before pregnancy or1st trimester excluded retrospective cohort (registry) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.98 [0.37;2.63] C
excluded (exposition period) 		4/1,374   1,496/506,155 1,500 1,374
ref
S5398
R14858		 Bérard (Controls exposed to non-Sertraline SSRI), 2015 Urinary system malformations 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 2.31 [0.59;8.97] C
excluded (control group) 		3/366   7/1,963 10 366
ref
S6705
R18930		 Bérard (Controls unexposed, sick), 2015 Urinary system 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) 0.86 [0.27;2.72] 3/366   141/14,868 144 366
ref
S5888
R14767		 Ban (Controls unexposed, disease free), 2014 Urinary system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.54 [0.08;3.76] -/757   815/325,294 - 757
ref
S6018
R15577		 Jimenez-Solem (Controls unexposed, NOS), 2012 Congenital malformations of the internal urinary system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.44 [0.06;3.11] 2/817   2,333/843,797 2,335 817
ref
S6159
R16158		 Louik, 2007 Renal-collecting-system defects 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.70 [0.70;4.20] 6/52   638/6,452 644 52
ref
Total 4 studies 1.07 [0.57;2.01] 3,123 1,992
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 Bérard (Controls unexposed, sick), 2015Bérard, 2015 1 0.86[0.27; 2.72]14436630%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Ban (Controls unexposed, disease free), 2014Ban, 2014 2 0.54[0.08; 3.76]-75711%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, NOS), 2012Jimenez-Solem, 2012 3 0.44[0.06; 3.11]2,33581710%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Louik, 2007Louik, 2007 1.70[0.70; 4.20]6445249%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (4 studies) I2 = 0% 1.07[0.57; 2.01]3,1231,9920.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed, disease free; 3: Controls unexposed, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.68[0.28; 1.65]2,4791,9400%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 3 case control studiescase control studies 1.70[0.69; 4.16]64452 -NALouik, 2007 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.10[0.48; 2.56]2,9791,62610%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Louik, 2007 3 unexposed, sickunexposed, sick 0.86[0.27; 2.73]144366 -NABérard (Controls unexposed, sick), 2015 1 Tags Adjustment   - Yes  - Yes 1.07[0.57; 2.01]3,1231,9920%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Louik, 2007 4 Monotherapy   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.86[0.27; 2.73]144366 -NABérard (Controls unexposed, sick), 2015 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.10[0.48; 2.56]2,9791,62610%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Louik, 2007 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.86[0.27; 2.73]144366 -NABérard (Controls unexposed, sick), 2015 1 All studiesAll studies 1.07[0.57; 2.01]3,1231,9920%NABérard (Controls unexposed, sick), 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Louik, 2007 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.42.41.2090.000Bérard (Controls unexposed, sick), 2015Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, NOS), 2012Louik, 2007

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

not enought points

p values plot
0.01.00.01.0

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) 1.10[0.48; 2.56]3,7851,62610%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Louik, 2007 3 unexposed, sick controlsunexposed, sick controls 0.86[0.27; 2.73]144366 -NABérard (Controls unexposed, sick), 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 2.31[0.59; 8.97]10366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0