Sertraline updated on 10-20-2025

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Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Congenital heart defects1.15 [1.01, 1.31]14%13 studies55,87224,718critical ROB1.58 [1.14; .]
All congenital malformations (majors, minors, majors and minors, or unspecified)1.07 [0.98, 1.16]0%11 studies134,69614,154low ROB-
Major congenital malformations1.07 [0.98, 1.17]0%11 studies133,92214,154low ROB-
Limb defects0.92 [0.70, 1.21]0%6 studies1,7193,717not evaluable ROB-
Digestive system anomalies1.16 [0.71, 1.88]0%6 studies3,4623,732not evaluable ROB-
Cleft palate0.82 [0.51, 1.35]0%4 studies4031,281not evaluable ROB-
Craniosynostosis1.88 [1.41, 2.51]0%6 studies1,7058,542not evaluable ROB3.16 [2.16; .]
Respiratory system anomalies2.30 [1.22, 4.35]5%6 studies1,0643,733serious ROB4.03 [1.74; .]
Ventricular septal defect0.87 [0.68, 1.12]0%5 studies12,45612,771not evaluable ROB-
Cardiac septal defects1.18 [0.99, 1.41]17%5 studies27,1467,693not evaluable ROB-
Genital anomalies0.68 [0.29, 1.61]0%3 studies1671,940not evaluable ROB-
Hypospadias1.07 [0.80, 1.42]0%5 studies8,07910,607not evaluable ROB-
Nervous system anomalies1.39 [0.83, 2.32]0%5 studies1223,717not evaluable ROB-
Urinary malformations1.07 [0.57, 2.01]0%4 studies3,1231,992not evaluable ROB-
Atrial septal defect1.31 [0.93, 1.83]0%4 studies3,9861,705not evaluable ROB-
Cleft lip with or without cleft palate0.80 [0.55, 1.18]0%3 studies704918not evaluable ROB-
Omphalocele2.07 [0.59, 7.21]55%3 studies142415not evaluable ROB-
Oro-facial clefts0.79 [0.56, 1.11]0%3 studies1,574not evaluable ROB-
Ano-rectal atresia and stenosis1.89 [0.98, 3.64]38%4 studies1,3947,308not evaluable ROB-
Club foot / Talipes equinovarus1.90 [1.35, 2.67]0%4 studies6,2227,354not evaluable ROB3.20 [2.04; .]
Ear, face and neck anomalies1.56 [0.43, 5.63]20%4 studies8292,496not evaluable ROB-
Eye defects0.82 [0.24, 2.86]0%4 studies1,2152,496not evaluable ROB-
Neural Tube Defects0.85 [0.54, 1.36]0%4 studies1,642931not evaluable ROB-
Atrioventricular septal defect1.62 [0.91, 2.88]0%3 studies1,3697,260not evaluable ROB-
Chromosomal abnormalities1.77 [0.77, 4.04]5%3 studies2,482not evaluable ROB-
Diaphragmatic hernia1.20 [0.66, 2.19]0%2 studies19247not evaluable ROB-
Transposition of the great vessels1.26 [0.70, 2.28]0%3 studies854884not evaluable ROB-
Coarctation of aorta1.29 [0.15, 11.40]85%2 studies57016not evaluable ROB-
Gastroschisis1.94 [0.49, 7.62]77%2 studies68not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)1.68 [0.93, 3.03]0%2 studies39814not evaluable ROB-
Limb reduction defects (LRD)2.83 [0.79, 10.15]9%2 studies97763not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.14 [0.38, 3.39]0%2 studies57142not evaluable ROB-
Pulmonary valve stenosis1.81 [1.22, 2.68]0%2 studies77215not evaluable ROB3.02 [1.75; .]
Tetralogy of Fallot1.80 [1.14, 2.84]0%2 studies42815not evaluable ROB2.99 [1.54; .]
Aortic valve atresia/stenosis--0 study-
Congenital glaucoma2.79 [1.12, 6.97]-1 studynot evaluable ROB5.02 [1.48; .]
Congenital hydronephrosis--0 study-
Ebstein's anomaly16.42 [2.10, 128.38]-1 study9315not evaluable ROB32.33 [3.62; .]
Encephalocele--0 study-
Hip dislocation and/or dysplasia--0 study-
Hirschsprung's disease--0 study-
Patent ductus arterious--0 study-
Polydactyly--0 study-
Pulmonary valve atresia--0 study-
Severe congenital heart defect2.88 [1.09, 7.61]-1 study2,93520not evaluable ROB5.21 [1.40; .]
Syndactyly--0 study-
9 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.28 [1.12, 1.45]30%8 studies159,15838,373not evaluable ROB1.87 [1.48; .]
Low birth weight (< 2500g)1.28 [1.10, 1.50]0%3 studies38,2762,053not evaluable ROB1.88 [1.43; .]
Small for gestational age (weight)0.99 [0.75, 1.32]23%3 studies239,18731,047not evaluable ROB-
Large for gestational age (weight)0.64 [0.29, 1.39]29%2 studies9,750692not evaluable ROB-
Large for gestational age (length)0.31 [0.13, 0.72]-1 studynot evaluable ROB5.91 [.; 2.11]
2 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.10 [1.00, 1.21]0%3 studies142,1062,032not evaluable ROB1.43 [1.02; .]
Postpartum hemorrhage1.25 [1.12, 1.40]0%3 studies30,4576,509not evaluable ROB1.81 [1.49; .]
Assisted deliveries (forceps, vacuum, ...)1.28 [0.98, 1.68]0%2 studies46,093692not evaluable ROB-
Preeclampsia1.17 [0.72, 1.90]40%2 studies4,8297,143not evaluable ROB-
Maternal consequences (as a whole)1.45 [1.20, 1.75]-1 study311,586643not evaluable ROB2.26 [1.70; .]
1 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)1.53 [1.06, 2.21]72%6 studies35,13135,433not evaluable ROB2.43 [1.32; .]
Neonatal medical care1.35 [0.91, 2.02]78%5 studies9,0607,510not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation3.43 [0.81, 14.60]93%4 studies6624,691not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.35 [0.93, 1.96]0%2 studies14,911692not evaluable ROB-
Persistent pulmonary hypertension2.75 [1.45, 5.23]6%3 studies2,3254,505not evaluable ROB4.95 [2.26; .]
Neonatal disorders (as a whole)2.01 [1.71, 2.36]-1 study161,729643not evaluable ROB3.43 [2.81; .]
Fetal distress1.18 [1.02, 1.37]-1 study12,8831,340not evaluable ROB1.64 [1.15; .]
4 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.47 [0.97, 2.24]0%2 studies1,210643not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.43 [1.32, 1.55]0%5 studies23,2194,589not evaluable ROB2.21 [1.96; .]
Intrauterine deaths (as a whole or unspecified)1.10 [0.91, 1.33]0%2 studies24,7171,189not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis1.25 [1.03, 1.51]0%6 studies1,77959,686not evaluable ROB1.80 [1.20; .]
ASD (Autism spectrum disorder): Diagnosis/Risk1.25 [1.03, 1.51]0%6 studies1,77959,686not evaluable ROB1.80 [1.20; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.05 [0.91, 1.21]0%2 studies1,86757,810not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.05 [0.91, 1.21]0%2 studies1,86757,810not evaluable ROB-
8 non statistically significant endpoints reported in only one study

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