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

Neonatal death (< 28 days of life)

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.
S18442
R78282		 Lee (Controls exposed to TCAs), 2025 Neonatal death (≤28 days after birth) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: SSRI only 1.26 [0.05;30.87] C
excluded (control group) 		1/1,465   0/613 1 1,465
ref
S18408
R77704		 Lee (Controls unexposed, general pop), 2025 Neonatal death (≤28 days after birth) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: SSRI only 0.44 [0.06;3.26] 1/1,465   627/463,440 628 1,465
ref
S5461
R24135		 Levy, 2020 Neonatal death (NOS) throughout pregnancy retrospective cohort unexposed (general population or NOS) Adjustment: No Matched Monotherapy: no or not specified 1.00 [0.02;51.01] C 0/82   0/82 0 82
ref
S5430
R21325		 Norby, 2016 Neonatal death (death within 28 days after birth) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 1.00 [0.70;1.50] -/17,736   -/718,533 - 17,736
ref
S7572
R23846		 Stephansson, 2013 Neonatal death (death within 0-27 days among live born infants) throughout pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.56 [0.86;2.83] 13/-   3,535/1,604,649 3,548 -
ref
Total 4 studies 1.11 [0.81;1.52] 4,176 19,283
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 Lee (Controls unexposed, general pop), 2025Lee, 2025 1 0.44[0.06; 3.26]6281,4653%ROB confusion: moderateROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Levy, 2020Levy, 2020 1.00[0.02; 51.01]0821%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Norby, 2016Norby, 2016 1.00[0.70; 1.50]-17,73669%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Stephansson, 2013Stephansson, 2013 1.56[0.86; 2.83]3,548-28%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 1.11[0.81; 1.52]4,17619,2830.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, general pop;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.11[0.81; 1.52]4,17619,2830%NALee (Controls unexposed, general pop), 2025 Levy, 2020 Norby, 2016 Stephansson, 2013 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.11[0.81; 1.52]4,17619,2830%NALee (Controls unexposed, general pop), 2025 Levy, 2020 Norby, 2016 Stephansson, 2013 4 Tags Adjustment   - No  - No 1.00[0.68; 1.46]-17,8180%NALevy, 2020 Norby, 2016 2   - Yes  - Yes 1.20[0.44; 3.28]4,1761,46529%NALee (Controls unexposed, general pop), 2025 Stephansson, 2013 2 MatchedMatched 1.00[0.02; 51.01]-82 -NALevy, 2020 1 Monotherapy   - no or not specified  - no or not specified 1.14[0.83; 1.57]3,54817,8180%NALevy, 2020 Norby, 2016 Stephansson, 2013 3   - SSRI only  - SSRI only 0.44[0.06; 3.24]6281,465 -NALee (Controls unexposed, general pop), 2025 1 All studiesAll studies 1.11[0.81; 1.52]4,17619,2830%NALee (Controls unexposed, general pop), 2025 Levy, 2020 Norby, 2016 Stephansson, 2013 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.74.82.4070.000Lee (Controls unexposed, general pop), 2025Levy, 2020Norby, 2016Stephansson, 2013

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 18442

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.11[0.81; 1.52]4,17619,2830%NALee (Controls unexposed, general pop), 2025 Levy, 2020 Norby, 2016 Stephansson, 2013 4 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.26[0.05; 30.87]11,465 -NALee (Controls exposed to TCAs), 2025 10.510.01.0