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

Cleft lip with or without 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
R76488		 Laspro - Sertraline, 2024 Any cleft lip (ICD 10 codes 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 1.17 [1.06;1.31]
excluded (exposition period) 		366/-   5,873/- 6,239 -
ref
S7467
R22123		 Anderson, 2020 Cleft lip w/without cleft palate 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: SSRI only 0.94 [0.73;1.19] -/-   0/- - -
ref
S5372
R18257		 Jordan, 2016 Cleft lip with or without 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 1.04 [0.62;1.74] C
excluded (exposition period) 		15/12,962   563/506,155 578 12,962
ref
S497
R16470		 Malm, 2011 Cleft lip with or without cleft palate 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.62 [0.25;1.51] -/6,976   -/628,607 - 6,976
ref
S5424
R16102		 Louik, 2007 Cleft lip with or without cleft palate 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.50 [0.90;2.50] 22/182   682/6,382 704 182
ref
Total 3 studies 1.02 [0.70;1.50] 704 7,158
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[0.73; 1.19]--54%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Malm, 2011Malm, 2011 0.62[0.25; 1.51]-6,97614%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Louik, 2007Louik, 2007 1.50[0.90; 2.50]70418231%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (3 studies) I2 = 47% 1.02[0.70; 1.50]7047,1580.25.01.0ROB: 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 0.62[0.25; 1.52]-6,976 -NAMalm, 2011 1 case control studiescase control studies 1.12[0.72; 1.75]70418262%NAAnderson, 2020 Louik, 2007 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.02[0.70; 1.50]7047,15847%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 Tags Adjustment   - Yes  - Yes 1.02[0.70; 1.50]7047,15847%NAAnderson, 2020 Malm, 2011 Louik, 2007 3 Monotherapy   - no or not specified  - no or not specified 1.05[0.45; 2.45]7047,15864%NAMalm, 2011 Louik, 2007 2   - SSRI only  - SSRI only 0.94[0.74; 1.20]-- -NAAnderson, 2020 1 All studiesAll studies 1.02[0.70; 1.50]7047,15847%NAAnderson, 2020 Malm, 2011 Louik, 2007 30.25.01.0

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.02[0.70; 1.50]7047,15847%NAAnderson, 2020 Malm, 2011 Louik, 2007 30.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Gao - SSRI (Cleft lip with or without cleft p ...Gao - SSRI (Cleft lip with or without cleft palate) 0.94[0.57; 1.55]-U,GPunexposed (general population or NOS)T11st trimesterstudies TTT3 metaPregmetaPreg 1.02[0.70; 1.50]47%7,158----Anderson, 2020 Malm, 2011 Louik, 2007 30.510.01.0