metaPreg - Ondansetron during pregnancy

Ondansetron

Table Graphic exposition period:

Adverse outcome	Verdict	OR 95%CI	I2	k	No. cases	No. exposed	publication bias
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)		1.04 [0.96, 1.12]	43%	8 studies	167,592	116,161	not evaluable
Cleft lip with or without cleft palate		1.03 [0.88, 1.21]	0%	7 studies	4,585	92,238	not evaluable
Congenital heart defects		1.13 [0.96, 1.33]	66%	6 studies	59,616	116,155	not evaluable
Major congenital malformations		1.02 [0.99, 1.05]	0%	7 studies	150,947	115,320	not evaluable
Ventricular septal defect		1.13 [0.99, 1.27]	25%	7 studies	19,110	96,086	not evaluable
Cleft palate		1.26 [0.87, 1.82]	65%	6 studies	3,363	91,261	not evaluable
Atrial septal defect		1.05 [0.79, 1.39]	84%	5 studies	5,715	91,265	not evaluable
Hypospadias		0.90 [0.70, 1.15]	0%	5 studies	3,323	1,874	not evaluable
Oro-facial clefts		1.20 [1.02, 1.40]	0%	4 studies	3,506	113,549	not evaluable
Atrioventricular septal defect		1.38 [0.65, 2.93]	73%	4 studies	6,190	90,765	not evaluable
Club foot / Talipes equinovarus		1.09 [0.83, 1.44]	0%	4 studies	1,061	2,714	not evaluable
Limb defects		1.02 [0.92, 1.11]	0%	4 studies	8,425	90,330	not evaluable
Ano-rectal atresia and stenosis		0.79 [0.49, 1.27]	0%	3 studies	671	1,881	not evaluable
Atresia or stenosis of other parts of small intestine		0.97 [0.61, 1.53]	0%	3 studies	394	1,880	not evaluable
Coarctation of aorta		0.95 [0.69, 1.29]	0%	3 studies	844	1,903	not evaluable
Diaphragmatic hernia		1.70 [1.17, 2.48]	0%	3 studies	875	2,394	not evaluable
Gastroschisis		0.89 [0.61, 1.29]	0%	3 studies	959	1,894	not evaluable
Hypoplastic left heart		1.49 [1.03, 2.17]	0%	3 studies	838	1,539	not evaluable
Pulmonary valve stenosis		1.08 [0.79, 1.48]	0%	3 studies	1,025	1,913	not evaluable
Severe congenital heart defect		0.76 [0.63, 0.93]	0%	2 studies	1,880	88,851	not evaluable
Single ventricle		0.90 [0.34, 2.37]	71%	2 studies	424	88,706	not evaluable
Total anomalous pulm venous return		0.84 [0.55, 1.30]	0%	2 studies	502	88,705	not evaluable
Abdominal wall defects		0.98 [0.90, 1.07]	0%	2 studies	8,816	89,679	not evaluable
Bilateral renal agenesis including Potter syndrome		1.85 [1.13, 3.02]	0%	2 studies	161	1,630	not evaluable
Cardiac septal defects		1.57 [1.17, 2.12]	43%	2 studies	39,475	2,528	not evaluable
Congenital cataract		0.94 [0.46, 1.91]	0%	2 studies	211	1,494	not evaluable
Digestive system anomalies		0.93 [0.85, 1.02]	0%	2 studies	9,598	89,700	not evaluable
Eye defects		0.95 [0.69, 1.30]	0%	2 studies	772	89,700	not evaluable
Genital anomalies		1.06 [0.97, 1.17]	0%	2 studies	7,100	89,679	not evaluable
Limb reduction defects		1.01 [0.39, 2.58]	0%	2 studies	563	2,115	not evaluable
Nervous system anomalies		0.94 [0.81, 1.09]	0%	2 studies	3,496	89,679	not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula		0.71 [0.40, 1.28]	0%	2 studies	364	1,496	not evaluable
Patent ductus arterious		0.90 [0.73, 1.11]	-	1 study	1,675	88,446	not evaluable
Respiratory system anomalies		1.13 [1.01, 1.27]	0%	2 studies	3,951	89,679	not evaluable
Spina bifida		1.24 [0.83, 1.83]	0%	2 studies	461	620	not evaluable
Transposition of the great vessels		0.80 [0.52, 1.23]	0%	2 studies	584	649	not evaluable
Urinary malformations		1.24 [0.76, 2.01]	0%	2 studies	176	89,679	not evaluable
Anophthalmos/micropthalmos		0.90 [0.31, 2.65]	-	1 study	132	257	not evaluable
Anotia		1.10 [0.59, 2.06]	-	1 study	354	263	not evaluable
Aortic valve atresia/stenosis		0.50 [0.20, 1.22]	-	1 study	272	260	not evaluable
Atresia of bile ducts		1.30 [0.51, 3.29]	-	1 study	101	258	not evaluable
Choanal atresia		1.33 [0.05, 32.76]	-	1 study	1	1,233	not evaluable
Congenital constriction bands/amniotic band		1.30 [0.51, 3.29]	-	1 study	155	258	not evaluable
Congenital glaucoma		4.00 [0.25, 64.04]	-	1 study	2	1,233	not evaluable
Congenital hydronephrosis		0.80 [0.17, 3.65]	-	1 study	12	1,233	not evaluable
Congenital skin disorders		0.57 [0.03, 11.07]	-	1 study	3	1,233	not evaluable
Ear malformations		1.67 [1.17, 2.38]	-	1 study	450	88,446	not evaluable
Ear, face and neck anomalies		4.00 [0.25, 64.04]	-	1 study	2	1,233	not evaluable
Ebstein's anomaly		1.10 [0.39, 3.11]	-	1 study	108	257	not evaluable
Hirschsprung's disease		1.20 [0.60, 2.40]	-	1 study	110	385	not evaluable
Hydrocephalus		1.40 [0.76, 2.57]	-	1 study	254	264	not evaluable
Intestinal malrotation		1.10 [0.57, 2.11]	-	1 study	125	385	not evaluable
Multicystic renal dysplasia		1.40 [0.83, 2.37]	-	1 study	176	394	not evaluable
Neural Tube Defects		0.60 [0.21, 1.70]	-	1 study	711	48	not evaluable
Omphalocele		1.10 [0.47, 2.56]	-	1 study	187	269	not evaluable
Polydactyly		0.36 [0.02, 6.58]	-	1 study	5	1,233	not evaluable
Pulmonary artery atresia		1.33 [0.05, 32.76]	-	1 study	1	1,233	not evaluable
Pulmonary artery stenosis		1.33 [0.05, 32.76]	-	1 study	1	1,233	not evaluable
Pulmonary valve atresia		0.70 [0.23, 2.10]	-	1 study	144	257	not evaluable
Situs inversus		0.70 [0.27, 1.81]	-	1 study	185	257	not evaluable
Syndactyly		2.67 [0.45, 15.99]	-	1 study	5	1,233	not evaluable
Tetralogy of Fallot		0.90 [0.57, 1.42]	-	1 study	616	274	not evaluable
Growth parameters and prematurity
Adverse outcome	Verdict	OR 95%CI	I2	k	No. cases	No. exposed	publication bias
preterm (< 37 weeks)		1.28 [0.76, 2.15]	79%	4 studies	8,576	3,213	not evaluable
low birth weight (< 2500g)		1.04 [0.61, 1.77]	50%	3 studies	7,451	2,147	not evaluable
small for gestational age (weight)		0.96 [0.69, 1.35]	67%	2 studies	50,664	2,047	not evaluable
Maternal consequences
Adverse outcome	Verdict	OR 95%CI	I2	k	No. cases	No. exposed	publication bias
Caesarean		1.63 [1.28, 2.07]	0%	2 studies	31,113	339	not evaluable
Preeclampsia		4.33 [0.21, 91.53]	-	1 study	2	100	not evaluable
Postpartum hemorrhage		1.20 [0.71, 2.03]	-	1 study	8,862	251	not evaluable
Neonatal disorders
Adverse outcome	Verdict	OR 95%CI	I2	k	No. cases	No. exposed	publication bias
Low Apgar score (< 7) (at 5 min)		1.89 [0.62, 5.75]	0%	2 studies	567	35	not evaluable
Neonatal medical care		1.21 [0.94, 1.55]	0%	2 studies	42,510	351	not evaluable
Persistent pulmonary hypertension		-	-	0 study
Low Apgar score (< 7) (at 1 min)		0.47 [0.04, 5.45]	-	1 study	3	35	not evaluable
Neonatal hypotension		1.52 [0.06, 37.69]	-	1 study	1	143	not evaluable
Neonatal tachypnea		1.27 [0.24, 6.70]	-	1 study	7	143	not evaluable
Long term consequences
Adverse outcome	Verdict	OR 95%CI	I2	k	No. cases	No. exposed	publication bias
Neuro-developmental disorders		1.34 [0.82, 2.17]	-	1 study	138	213	not evaluable
Intrauterine deaths
Adverse outcome	Verdict	OR 95%CI	I2	k	No. cases	No. exposed	publication bias
Late intrauterine deaths (> 22 weeks)		1.11 [0.60, 2.05]	0%	4 studies	679	3,424	not evaluable
Early intrauterine death (< 22 weeks)		0.40 [0.32, 0.50]	0%	3 studies	642	3,095	not evaluable
Ectopic pregnancy		1.82 [0.37, 8.83]	-	1 study	9	1,070	not evaluable
Elective termination of pregnancy		1.10 [0.71, 1.70]	-	1 study	86	1,070	not evaluable
Therapeutic terminations of pregnancy		5.06 [0.24, 106.12]	-	1 study	2	176	not evaluable
Intrauterine deaths (as a whole)		0.28 [0.01, 6.96]	-	1 study	1	100	not evaluable
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