Sertraline updated on 07-01-2025

Preterm (< 37 weeks)

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.
S18438
R78190		 Lee (Controls exposed to TCAs), 2025 Preterm birth (infant born at gestational age <37 weeks) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.00 [0.69;1.46] C
excluded (control group) 		61/643   58/613 119 643
ref
S18420
R77948		 Lee (Controls unexposed, general pop), 2025 Preterm birth (infant born at gestational age <37 weeks) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.28 [0.98;1.68] 61/643   28,543/463,440 28,604 643
ref
S18304
R77081		 Martin, 2024 Preterm delivery (delivery at <259 days (37 weeks’)) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.29 [1.23;1.35] 2,418/34,604   119,950/2,408,707 122,368 34,604
ref
S12953
R49162		 Heinonen, 2021 Preterm birth (< 37 weeks) 2nd and/or 3rd trimester randomized controlled trial unexposed, sick Adjustment: Randomisation Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.79 [0.02;25.90] C 1/11   0/3 1 11
ref
S13130
R50076		 Marks (Controls exposed to Bupropion), 2021 Preterm Birth during pregnancy (anytime or not specified) retrospective cohort exposed to other treatment, sick Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.95 [0.70;1.29] C 238/1,653   61/406 299 1,653
ref
S7699
R22872		 Kivistö, 2016 Preterm delivery (birth before 37 completed weeks) during pregnancy (anytime or not specified) retrospective cohort unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.94 [0.29;3.06] -/49   1,909/24,402 - 49
ref
S7522
R22551		 Ozturk (Sertraline), 2016 Preterm Births (<37 weeks) at least 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.85 [0.05;15.32] C 0/17   8/246 8 17
ref
S7178
R20146		 Colvin, 2011 Preterm birth (<37 weeks) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.62 [1.30;2.03] 159/1,340   7,480/92,995 7,639 1,340
ref
S5929
R15112		 Calderon-Margalit, 2009 Preterm delivery (before 37 weeks of gestation) during pregnancy (anytime or not specified) prospective cohort unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.65 [0.23;1.83] 5/56   234/2,493 239 56
ref
Total 8 studies 1.28 [1.12;1.45] 159,158 38,373
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 1.28[0.98; 1.68]28,60464316%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Martin, 2024Martin, 2024 1.29[1.23; 1.35]122,36834,60447%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Heinonen, 2021Heinonen, 2021 0.79[0.02; 25.90]1110%ROB confusion: unclearROB selection: lowROB classification: lowROB missing: criticalROB mesure: lowROB reporting: low Marks (Controls exposed to Bupropion), 2021Marks, 2021 2 0.95[0.70; 1.29]2991,65313%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Kivistö, 2016Kivistö, 2016 0.94[0.29; 3.06]-491%ROB confusion: seriousROB selection: criticalROB classification: moderateROB missing: criticalROB mesure: moderateROB reporting: moderate Ozturk (Sertraline), 2016Ozturk, 2016 3 0.85[0.05; 15.32]8170%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Colvin, 2011Colvin, 2011 1.62[1.30; 2.03]7,6391,34020%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Calderon-Margalit, 2009Calderon-Margalit, 2009 0.65[0.23; 1.83]239562%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Total (8 studies) I2 = 30% 1.28[1.12; 1.45]159,15838,3730.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, general pop; 2: Controls exposed to Bupropion; 3: Sertraline;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.27[1.10; 1.46]159,15738,36239%NALee (Controls unexposed, general pop), 2025 Martin, 2024 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 Ozturk (Sertraline), 2016 Colvin, 2011 Calderon-Margalit, 2009 7 case control studiescase control studies 0 RCTRCT 0.79[0.02; 25.90]111 -NAHeinonen, 2021 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.33[1.19; 1.47]158,85836,70916%NALee (Controls unexposed, general pop), 2025 Martin, 2024 Kivistö, 2016 Ozturk (Sertraline), 2016 Colvin, 2011 Calderon-Margalit, 2009 6 unexposed, sickunexposed, sick 0.79[0.02; 25.90]111 -NAHeinonen, 2021 1 exposed to other treatment, sickexposed to other treatment, sick 0.95[0.70; 1.29]2991,653 -NAMarks (Controls exposed to Bupropion), 2021 1 Tags Adjustment   - No  - No 0.95[0.70; 1.29]3071,6700%NAMarks (Controls exposed to Bupropion), 2021 Ozturk (Sertraline), 2016 2   - Randomisation  - Randomisation 0.79[0.02; 25.90]111 -NAHeinonen, 2021 1   - Yes  - Yes 1.34[1.17; 1.52]158,85036,69232%NALee (Controls unexposed, general pop), 2025 Martin, 2024 Kivistö, 2016 Colvin, 2011 Calderon-Margalit, 2009 5 Monotherapy   - no or not specified  - no or not specified 0.67[0.25; 1.78]247730%NAOzturk (Sertraline), 2016 Calderon-Margalit, 2009 2   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.27[1.20; 1.35]151,27236,9602%NALee (Controls unexposed, general pop), 2025 Martin, 2024 Heinonen, 2021 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 5   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.62[1.30; 2.02]7,6391,340 -NAColvin, 2011 1 All studiesAll studies 1.28[1.12; 1.45]159,15838,37330%NALee (Controls unexposed, general pop), 2025 Martin, 2024 Heinonen, 2021 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 Ozturk (Sertraline), 2016 Colvin, 2011 Calderon-Margalit, 2009 80.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.24.42.1370.000Lee (Controls unexposed, general pop), 2025Martin, 2024Heinonen, 2021Marks (Controls exposed to Bupropion), 2021Kivistö, 2016Ozturk (Sertraline), 2016Colvin, 2011Calderon-Margalit, 2009

Asymetry test p-value = 0.4292 (by Egger's regression)

slope=0.2707 (0.0331); intercept=-0.4388 (0.5177); t=0.8475; p=0.4292

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 18438

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.33[1.19; 1.47]160,75836,70916%NALee (Controls unexposed, general pop), 2025 Martin, 2024 Kivistö, 2016 Ozturk (Sertraline), 2016 Colvin, 2011 Calderon-Margalit, 2009 6 unexposed, sick controlsunexposed, sick controls 0.79[0.02; 25.90]111 -NAHeinonen, 2021 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.97[0.77; 1.23]4182,2960%NALee (Controls exposed to TCAs), 2025 Marks (Controls exposed to Bupropion), 2021 20.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Xing (Preterm birth)Xing (Preterm birth) 1.59[1.28; 1.97]0%-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT2 Vlenterie (Preterm birth (delivery before 37 ...Vlenterie (Preterm birth (delivery before 37 weeks of gestation)) 2.20[1.20; 4.30]-U,GPunexposed (general population or NOS)Anyduring pregnancy (anytime or not specified)studies TTT7 Vlenterie (Preterm birth (delivery before 37 ...Vlenterie (Preterm birth (delivery before 37 weeks of gestation)) 2.00[0.90; 4.30]-U,Sunexposed, sickAnyduring pregnancy (anytime or not specified)studies TTT7 metaPregmetaPreg 1.28[1.12; 1.45]30%38,373----Lee (Controls unexposed, general pop), 2025 Martin, 2024 Heinonen, 2021 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 Ozturk (Sertraline), 2016 Colvin, 2011 Calderon-Margalit, 2009 80.510.01.0