Ondansetron

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Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
All congenital malformations (majors, minors, majors and minors, or unspecified)1.04 [0.96, 1.12]43%8 studies167,592116,161not evaluable ROB
Cleft lip with or without cleft palate1.01 [0.84, 1.21]0%6 studies3,75791,970not evaluable ROB
Congenital heart defects1.13 [0.96, 1.33]66%6 studies59,616116,155not evaluable ROB
Major congenital malformations1.02 [0.99, 1.05]0%7 studies150,947115,320not evaluable ROB
Ventricular septal defect1.15 [1.01, 1.32]28%6 studies17,76595,806not evaluable ROB
Cleft palate1.17 [0.72, 1.90]67%5 studies2,94591,009not evaluable ROB
Atrial septal defect1.09 [0.79, 1.50]87%4 studies4,51090,971not evaluable ROB
Atrioventricular septal defect1.38 [0.65, 2.93]73%4 studies6,19090,765not evaluable ROB
Oro-facial clefts1.20 [1.02, 1.40]0%4 studies3,506113,549not evaluable ROB
Club foot / Talipes equinovarus1.13 [0.85, 1.50]0%4 studies9852,710not evaluable ROB
Hypospadias0.97 [0.71, 1.33]0%4 studies2,6101,729not evaluable ROB
Limb defects1.03 [0.93, 1.13]0%3 studies7,82490,061not evaluable ROB
Urinary malformations1.23 [1.03, 1.46]0%4 studies8,86591,075not evaluable ROB
Ano-rectal atresia and stenosis0.54 [0.21, 1.38]0%2 studies1151,613not evaluable ROB
Atresia or stenosis of other parts of small intestine1.01 [0.57, 1.78]0%2 studies1561,620not evaluable ROB
Coarctation of aorta0.70 [0.41, 1.19]0%2 studies2011,619not evaluable ROB
Craniosynostosis1.13 [0.95, 1.35]0%3 studies12,7652,512not evaluable ROB
Diaphragmatic hernia1.70 [1.17, 2.48]0%3 studies8752,394not evaluable ROB
Gastroschisis0.99 [0.58, 1.70]0%2 studies1961,624not evaluable ROB
Hypoplastic left heart (HLH/HLHS)1.49 [0.86, 2.57]0%2 studies4601,267not evaluable ROB
Pulmonary valve stenosis0.84 [0.48, 1.49]0%2 studies2301,623not evaluable ROB
Severe congenital heart defect0.76 [0.63, 0.93]0%2 studies1,88088,851not evaluable ROB
Single ventricle0.90 [0.34, 2.37]71%2 studies42488,706not evaluable ROB
Total anomalous pulm venous return0.84 [0.55, 1.30]0%2 studies50288,705not evaluable ROB
Abdominal wall defects0.98 [0.90, 1.07]0%2 studies8,81689,679not evaluable ROB
Bilateral renal agenesis including Potter syndrome1.85 [1.13, 3.02]0%2 studies1611,630not evaluable ROB
Cardiac septal defects1.57 [1.17, 2.12]43%2 studies39,4752,528not evaluable ROB
Congenital cataract0.94 [0.46, 1.91]0%2 studies2111,494not evaluable ROB
Digestive system anomalies0.93 [0.85, 1.02]0%2 studies9,59889,700not evaluable ROB
Eye defects0.95 [0.69, 1.30]0%2 studies77289,700not evaluable ROB
Genital anomalies1.06 [0.97, 1.17]0%2 studies7,10089,679not evaluable ROB
Limb reduction defects (LRD)1.01 [0.39, 2.58]0%2 studies5632,115not evaluable ROB
Nervous system anomalies0.94 [0.81, 1.09]0%2 studies3,49689,679not evaluable ROB
Oesophageal atresia with or without tracheo-oesophageal fistula0.71 [0.40, 1.28]0%2 studies3641,496not evaluable ROB
Respiratory system anomalies1.13 [1.01, 1.27]0%2 studies3,95189,679not evaluable ROB
Ear malformations1.67 [1.17, 2.38]-1 study45088,446not evaluable ROB
29 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Preterm (< 37 weeks)1.28 [0.76, 2.15]79%4 studies8,5763,213not evaluable ROB
Low birth weight (< 2500g)1.04 [0.61, 1.77]50%3 studies7,4512,147not evaluable ROB
Small for gestational age (weight)0.96 [0.69, 1.35]67%2 studies50,6642,047not evaluable ROB

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Caesarean1.63 [1.28, 2.07]0%2 studies31,113339not evaluable ROB
Preeclampsia1.54 [0.93, 2.56]0%2 studies4,362351not evaluable ROB
1 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Low Apgar score (< 7) (at 5 min)1.89 [0.62, 5.75]0%2 studies56735not evaluable ROB
Neonatal medical care1.21 [0.94, 1.55]0%2 studies42,510351not evaluable ROB
Persistent pulmonary hypertension--0 study
3 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
Late intrauterine deaths (> 22 weeks)1.11 [0.60, 2.05]0%4 studies6793,424not evaluable ROB
Early intrauterine death (< 22 weeks)0.40 [0.32, 0.50]0%3 studies6423,095not evaluable ROB
4 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROB
1 non statistically significant endpoints reported in only one study

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