Selective Serotonin Reuptake Inhibitor (SSRI) 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.
S18236
R76492		 Laspro - Sertraline, 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
S7467
R22122		 Anderson, 2020 Cleft palate only 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: SSRI only 0.97 [0.71;1.32] -/-   0/- - -
ref
S5372
R18258		 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 0.92 [0.43;1.94] C
excluded (exposition period) 		7/12,962   298/506,155 305 12,962
ref
S6704
R18921		 Bérard - Non Sertraline SSRI, 2015 Cleft palate 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) 0.29 [0.04;2.15] C 1/1,963   26/14,868 27 1,963
ref
S497
R16471		 Malm, 2011 Cleft palate 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.18 [0.67;2.08] -/6,976   -/628,607 - 6,976
ref
S5424
R16107		 Louik, 2007 Cleft palate alone 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.90 [0.40;2.00] 7/167   370/6,070 377 167
ref
Total 4 studies 0.98 [0.76;1.27] 404 9,106
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 0.97[0.71; 1.32]--68%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Bérard - Non Sertraline SSRI, 2015Bérard - Non Sertraline SSRI, 2015 0.29[0.04; 2.15]271,9632%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 1.18[0.67; 2.08]-6,97620%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Louik, 2007Louik, 2007 0.90[0.40; 2.00]37716710%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (4 studies) I2 = 0% 0.98[0.76; 1.27]4049,1060.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.82[0.25; 2.73]278,93943%NABérard - Non Sertraline SSRI, 2015 Malm, 2011 2 case control studiescase control studies 0.96[0.72; 1.28]3771670%NAAnderson, 2020 Louik, 2007 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.00[0.77; 1.30]3777,1430%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 unexposed, sickunexposed, sick 0.29[0.04; 2.15]271,963 -NABérard - Non Sertraline SSRI, 2015 1 Tags Adjustment   - No  - No 0.29[0.04; 2.15]271,963 -NABérard - Non Sertraline SSRI, 2015 1   - Yes  - Yes 1.00[0.77; 1.30]3777,1430%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 Monotherapy   - no or not specified  - no or not specified 1.08[0.68; 1.71]3777,1430%NAMalm, 2011 Louik, 2007 2   - SSRI only  - SSRI only 0.81[0.35; 1.88]271,96327%NAAnderson, 2020 Bérard - Non Sertraline SSRI, 2015 2 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.29[0.04; 2.15]271,963 -NABérard - Non Sertraline SSRI, 2015 1 All studiesAll studies 0.98[0.76; 1.27]4049,1060%NAAnderson, 2020 Bérard - Non Sertraline SSRI, 2015 Malm, 2011 Louik, 2007 40.15.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.42.41.2230.000Anderson, 2020Bérard - Non Sertraline SSRI, 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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.00[0.77; 1.30]3777,1430%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 unexposed, sick controlsunexposed, sick controls Out of scale0.29[0.04; 2.15]271,963 -NABérard - Non Sertraline SSRI, 2015 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Gao - SSRI (Cleft palate)Gao - SSRI (Cleft palate) 1.18[0.76; 1.81]-U,GPunexposed (general population or NOS)T11st trimesterstudies TTT3 metaPregmetaPreg 0.98[0.76; 1.27]0%9,106----Anderson, 2020 Bérard - Non Sertraline SSRI, 2015 Malm, 2011 Louik, 2007 40.510.01.0