Sertraline updated on 07-01-2025

Cleft palate

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.
S18305
R77090		 Laspro, 2024 Isolated Cleft Palate (ICD-10 code Q35 excluding Q36 or Q37) during pregnancy (anytime or not specified) excluded nested case control unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 1.33 [1.20;1.47]
excluded (exposition period) 		385/-   5,474/- 5,859 -
ref
S7468
R22180		 Anderson, 2020 Cleft palate only 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.81 [0.47;1.39] -/-   0/- - -
ref
S8217
R25649		 Jordan, 2016 Cleft palate 3 months or more before pregnancy or1st trimester excluded retrospective cohort (registry) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 2.47 [0.62;9.95] C
excluded (exposition period) 		2/1,374   298/506,155 300 1,374
ref
S5398
R14864		 Bérard (Controls exposed to non-Sertraline SSRI), 2015 Cleft palate 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.79 [0.07;44.00] C
excluded (control group) 		0/366   1/1,963 1 366
ref
S6705
R18936		 Bérard (Controls unexposed, sick), 2015 Cleft palate 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) 0.77 [0.05;12.60] C 0/366   26/14,868 26 366
ref
S6244
R16523		 Malm, 2011 Cleft palate 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.42 [0.35;5.76] -/869   -/628,607 - 869
ref
S6159
R16161		 Louik, 2007 Cleft palate alone 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.17 [0.01;2.70] C 0/46   377/6,191 377 46
ref
Total 4 studies 0.82 [0.51;1.35] 403 1,281
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 0.81[0.47; 1.39]--82%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: unclearROB reporting: moderate Bérard (Controls unexposed, sick), 2015Bérard, 2015 1 0.77[0.05; 12.60]263663%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Malm, 2011Malm, 2011 1.42[0.35; 5.76]-86912%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Louik, 2007Louik, 2007 0.17[0.01; 2.70]377463%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (4 studies) I2 = 0% 0.82[0.51; 1.35]4031,2810.05.01.0ROB: 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 1.26[0.36; 4.39]261,2350%NABérard (Controls unexposed, sick), 2015 Malm, 2011 2 case control studiescase control studies 0.68[0.25; 1.81]3774616%NAAnderson, 2020 Louik, 2007 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.83[0.50; 1.36]3779150%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 unexposed, sickunexposed, sick 0.77[0.05; 12.60]26366 -NABérard (Controls unexposed, sick), 2015 1 Tags Adjustment   - No  - No 0.36[0.05; 2.56]4034120%NABérard (Controls unexposed, sick), 2015 Louik, 2007 2   - Yes  - Yes 0.87[0.53; 1.44]-8690%NAAnderson, 2020 Malm, 2011 2 Monotherapy   - no or not specified  - no or not specified 1.42[0.35; 5.76]-869 -NAMalm, 2011 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.81[0.47; 1.38]263660%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.17[0.01; 2.70]37746 -NALouik, 2007 1 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.77[0.05; 12.60]26366 -NABérard (Controls unexposed, sick), 2015 1 All studiesAll studies 0.82[0.51; 1.35]4031,2810%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 Malm, 2011 Louik, 2007 40.05.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.43.21.7140.000Anderson, 2020Bérard (Controls unexposed, sick), 2015Malm, 2011Louik, 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) 0.83[0.50; 1.36]3779150%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 unexposed, sick controlsunexposed, sick controls 0.77[0.05; 12.60]26366 -NABérard (Controls unexposed, sick), 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.79[0.07; 44.00]1366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0