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Ondansetron
Overall results
Study description
Excluded studies
Table
Graphic
auto
during pregnancy (anytime or not specified)
1st trimester
2nd trimester
3rd trimester
2nd and/or 3rd trimester
throughout pregnancy
early pregnancy
days before delivery
late pregnancy
preconception-only
periconceptional
preconceptional for kinetic reason
at least 1st trimester
3 months (or more) before pregnancy or during pregnancy
1st and 2nd trimester
3 months or more before pregnancy or1st trimester
Whatever the period exposition
individual studies
Outcome
TE
95% CI
n cases
n exposed
k
Pub. bias
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)
Einarson (Unexposed control), 2004 Andersen, 2013 Ozdemirci, 2014 Danielsson, 2014 Fejzo (Unexposed control, disease free), 2016 Huybrechts (Unexposed control), 2018 Bérard, 2019 Huybrechts, 2019
8
1.04
[
0.96
; 1.12]
167,592
116,161
not evaluable
Cleft lip with or without cleft palate
Anderka, 2012 Pasternak, 2013 Fejzo (Unexposed control, disease free), 2016 Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018 Parker, NBDPS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
7
1.03
[
0.88
; 1.21]
4,585
92,238
not evaluable
Congenital heart defects
Andersen, 2013 Danielsson, 2014 Fejzo (Unexposed control, disease free), 2016 Huybrechts (Unexposed control), 2018 Zambelli-Weiner (Unexposed control, sick), 2019 Huybrechts, 2019
6
1.13
[
0.96
; 1.33]
59,616
116,155
not evaluable
Major congenital malformations
Einarson (Unexposed control), 2004 Colvin, 2013 Andersen, 2013 Danielsson, 2014 Huybrechts (Unexposed control), 2018 Bérard, 2019 Huybrechts, 2019
7
1.02
[
0.99
; 1.05]
150,947
115,320
not evaluable
Ventricular septal defect
Pasternak, 2013 Fejzo (Unexposed control, disease free), 2016 Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018 Parker, NBDPS study, 2018 Lemon, 2019 Zambelli-Weiner (Unexposed control, NOS), 2019
7
1.13
[
0.99
; 1.27]
19,110
96,086
not evaluable
Cleft palate
Anderka, 2012 Pasternak, 2013 Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018 Parker, NBDPS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
6
1.26
[
0.87
; 1.82]
3,363
91,261
not evaluable
Oro-facial clefts
Pasternak, 2013 Huybrechts (Unexposed control), 2018 Huybrechts, 2019 Zambelli-Weiner (Unexposed control, sick), 2019
4
1.20
[
1.02
; 1.40]
3,506
113,549
not evaluable
Atrial septal defect
Pasternak, 2013 Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018 Parker, NBDPS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
5
1.05
[
0.79
; 1.39]
5,715
91,265
not evaluable
Atrioventricular septal defect
Pasternak, 2013 Huybrechts (Unexposed control), 2018 Parker, NBDPS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
4
1.38
[
0.65
; 2.93]
6,190
90,765
not evaluable
Club foot / Talipes equinovarus
Pasternak, 2013 Werler, 2014 Fejzo (Unexposed control, disease free), 2016 Parker, BDS study, 2018
4
1.13
[
0.85
; 1.50]
985
2,710
not evaluable
Hypospadias
Anderka, 2012 Lind, 2013 Pasternak, 2013 Parker, BDS study, 2018 Parker, NBDPS study, 2018
5
0.90
[
0.70
; 1.15]
3,323
1,874
not evaluable
Limb defects
Pasternak, 2013 Parker, BDS study, 2018 Parker, NBDPS study, 2018 Huybrechts (Unexposed control), 2018
4
1.02
[
0.92
; 1.11]
8,425
90,330
not evaluable
Urinary malformations
Pasternak, 2013 Parker, BDS study, 2018 Huybrechts (Unexposed control), 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
4
1.23
[
1.03
; 1.46]
8,865
91,075
not evaluable
Ano-rectal atresia and stenosis
Pasternak, 2013 Parker, NBDPS study, 2018 Parker, BDS study, 2018
3
0.79
[
0.49
; 1.27]
671
1,881
not evaluable
Atresia or stenosis of other parts of small intestine
Pasternak, 2013 Parker, NBDPS study, 2018 Parker, BDS study, 2018
3
0.97
[
0.61
; 1.53]
394
1,880
not evaluable
Coarctation of aorta
Pasternak, 2013 Parker, NBDPS study, 2018 Parker, BDS study, 2018
3
0.95
[
0.69
; 1.29]
844
1,903
not evaluable
Craniosynostosis
Pasternak, 2013 Parker, NBDPS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
3
1.13
[
0.95
; 1.35]
12,765
2,512
not evaluable
Diaphragmatic hernia
Pasternak, 2013 Parker, NBDPS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
3
1.70
[
1.17
; 2.48]
875
2,394
not evaluable
Gastroschisis
Pasternak, 2013 Parker, NBDPS study, 2018 Parker, BDS study, 2018
3
0.89
[
0.61
; 1.29]
959
1,894
not evaluable
Hypoplastic left heart (HLH/HLHS)
Parker, NBDPS study, 2018 Parker, BDS study, 2018 Zambelli-Weiner (Unexposed control, NOS), 2019
3
1.49
[
1.03
; 2.17]
838
1,539
not evaluable
Pulmonary valve stenosis
Pasternak, 2013 Parker, NBDPS study, 2018 Parker, BDS study, 2018
3
1.08
[
0.79
; 1.48]
1,025
1,913
not evaluable
Severe congenital heart defect
Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018
2
0.76
[
0.63
; 0.93]
1,880
88,851
not evaluable
Single ventricle
Parker, NBDPS study, 2018 Huybrechts (Unexposed control), 2018
2
0.90
[
0.34
; 2.37]
424
88,706
not evaluable
Total anomalous pulm venous return
Parker, NBDPS study, 2018 Huybrechts (Unexposed control), 2018
2
0.84
[
0.55
; 1.30]
502
88,705
not evaluable
Abdominal wall defects
Pasternak, 2013 Huybrechts (Unexposed control), 2018
2
0.98
[
0.90
; 1.07]
8,816
89,679
not evaluable
Bilateral renal agenesis including Potter syndrome
Pasternak, 2013 Parker, BDS study, 2018
2
1.85
[
1.13
; 3.02]
161
1,630
not evaluable
Cardiac septal defects
Danielsson, 2014 Zambelli-Weiner (Unexposed control, NOS), 2019
2
1.57
[
1.17
; 2.12]
39,475
2,528
not evaluable
Congenital cataract
Pasternak, 2013 Parker, NBDPS study, 2018
2
0.94
[
0.46
; 1.91]
211
1,494
not evaluable
Digestive system anomalies
Pasternak, 2013 Huybrechts (Unexposed control), 2018
2
0.93
[
0.85
; 1.02]
9,598
89,700
not evaluable
Eye defects
Pasternak, 2013 Huybrechts (Unexposed control), 2018
2
0.95
[
0.69
; 1.30]
772
89,700
not evaluable
Genital anomalies
Pasternak, 2013 Huybrechts (Unexposed control), 2018
2
1.06
[
0.97
; 1.17]
7,100
89,679
not evaluable
Limb reduction defects (LRD)
Pasternak, 2013 Zambelli-Weiner (Unexposed control, NOS), 2019
2
1.01
[
0.39
; 2.58]
563
2,115
not evaluable
Nervous system anomalies
Pasternak, 2013 Huybrechts (Unexposed control), 2018
2
0.94
[
0.81
; 1.09]
3,496
89,679
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Pasternak, 2013 Parker, NBDPS study, 2018
2
0.71
[
0.40
; 1.28]
364
1,496
not evaluable
Patent ductus arterious
Huybrechts (Unexposed control), 2018
1
0.90
[
0.73
; 1.11]
1,675
88,446
not evaluable
Respiratory system anomalies
Pasternak, 2013 Huybrechts (Unexposed control), 2018
2
1.13
[
1.01
; 1.27]
3,951
89,679
not evaluable
Spina bifida
Parker, NBDPS study, 2018 Parker, BDS study, 2018
2
1.24
[
0.83
; 1.83]
461
620
not evaluable
Transposition of the great vessels
Parker, NBDPS study, 2018 Parker, BDS study, 2018
2
0.80
[
0.52
; 1.23]
584
649
not evaluable
Anophthalmos/micropthalmos
Parker, NBDPS study, 2018
1
0.90
[
0.31
; 2.65]
132
257
not evaluable
Anotia
Parker, NBDPS study, 2018
1
1.10
[
0.59
; 2.06]
354
263
not evaluable
Aortic valve atresia/stenosis
Parker, NBDPS study, 2018
1
0.50
[
0.20
; 1.22]
272
260
not evaluable
Atresia of bile ducts
Parker, NBDPS study, 2018
1
1.30
[
0.51
; 3.29]
101
258
not evaluable
Bladder exstrophy and/or epispadia
Pasternak, 2013
1
1.33
[
0.05
; 32.76]
1
1,233
not evaluable
Choanal atresia
Pasternak, 2013
1
1.33
[
0.05
; 32.76]
1
1,233
not evaluable
Congenital constriction bands/amniotic band
Parker, NBDPS study, 2018
1
1.30
[
0.51
; 3.29]
155
258
not evaluable
Congenital glaucoma
Pasternak, 2013
1
4.00
[
0.25
; 64.04]
2
1,233
not evaluable
Congenital hydronephrosis
Pasternak, 2013
1
0.80
[
0.17
; 3.65]
12
1,233
not evaluable
Congenital skin disorders
Pasternak, 2013
1
0.57
[
0.03
; 11.07]
3
1,233
not evaluable
Ear malformations
Huybrechts (Unexposed control), 2018
1
1.67
[
1.17
; 2.38]
450
88,446
not evaluable
Ear, face and neck anomalies
Pasternak, 2013
1
4.00
[
0.25
; 64.04]
2
1,233
not evaluable
Ebstein's anomaly
Parker, NBDPS study, 2018
1
1.10
[
0.39
; 3.11]
108
257
not evaluable
Hirschsprung's disease
Parker, BDS study, 2018
1
1.20
[
0.60
; 2.40]
110
385
not evaluable
Hydrocephaly
Parker, NBDPS study, 2018
1
1.40
[
0.76
; 2.57]
254
264
not evaluable
Intestinal malrotation
Parker, BDS study, 2018
1
1.10
[
0.57
; 2.11]
125
385
not evaluable
Microcephaly / Small head circumference for gestational age
Kerr, 2018
1
0.99
[
0.18
; 5.53]
57
428
not evaluable
Multicystic renal dysplasia
Parker, BDS study, 2018
1
1.40
[
0.83
; 2.37]
176
394
not evaluable
Neural Tube Defects
Anderka, 2012
1
0.60
[
0.21
; 1.70]
711
48
not evaluable
Omphalocele
Parker, NBDPS study, 2018
1
1.10
[
0.47
; 2.56]
187
269
not evaluable
Polydactyly
Pasternak, 2013
1
0.36
[
0.02
; 6.58]
5
1,233
not evaluable
Pulmonary artery atresia
Pasternak, 2013
1
1.33
[
0.05
; 32.76]
1
1,233
not evaluable
Pulmonary artery stenosis
Pasternak, 2013
1
1.33
[
0.05
; 32.76]
1
1,233
not evaluable
Pulmonary valve atresia
Parker, NBDPS study, 2018
1
0.70
[
0.23
; 2.10]
144
257
not evaluable
Situs inversus
Parker, NBDPS study, 2018
1
0.70
[
0.27
; 1.81]
185
257
not evaluable
Syndactyly
Pasternak, 2013
1
2.67
[
0.45
; 15.99]
5
1,233
not evaluable
Tetralogy of Fallot
Parker, NBDPS study, 2018
1
0.90
[
0.57
; 1.42]
616
274
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Pasternak, 2013 Colvin, 2013 Ozdemirci, 2014 Fejzo (Unexposed control, disease free), 2016
4
1.28
[
0.76
; 2.15]
8,576
3,213
not evaluable
Low birth weight (< 2500g)
Pasternak, 2013 Colvin, 2013 Ozdemirci, 2014
3
1.04
[
0.61
; 1.77]
7,451
2,147
not evaluable
Small for gestational age (weight)
Pasternak, 2013 Colvin, 2013
2
0.96
[
0.69
; 1.35]
50,664
2,047
not evaluable
Maternal consequences
Caesarean
Colvin, 2013 Shahraki, 2016
2
1.63
[
1.28
; 2.07]
31,113
339
not evaluable
Preeclampsia
Colvin, 2013 Ozdemirci, 2014
2
1.54
[
0.93
; 2.56]
4,362
351
not evaluable
Postpartum hemorrhage
Colvin, 2013
1
1.20
[
0.71
; 2.03]
8,862
251
not evaluable
Neonatal disorders
Low Apgar score (< 7) (at 5 min)
Colvin, 2013 Marciniak, 2015
2
1.89
[
0.62
; 5.75]
567
35
not evaluable
Neonatal medical care
Colvin, 2013 Shahraki, 2016
2
1.21
[
0.94
; 1.55]
42,510
351
not evaluable
Persistent pulmonary hypertension
0
-
-
-
-
-
Low Apgar score (< 7) (at 1 min)
Marciniak, 2015
1
0.47
[
0.04
; 5.45]
3
35
not evaluable
Neonatal hypotension
Oofuvong, 2018
1
1.52
[
0.06
; 37.69]
1
143
not evaluable
Neonatal tachypnea
Oofuvong, 2018
1
1.27
[
0.24
; 6.70]
7
143
not evaluable
Intrauterine deaths
Late intrauterine deaths (> 22 weeks)
Einarson (Unexposed control), 2004 Pasternak, 2013 Colvin, 2013 Fejzo (Unexposed control, disease free), 2016
4
1.11
[
0.60
; 2.05]
679
3,424
not evaluable
Early intrauterine death (< 22 weeks)
Einarson (Unexposed control), 2004 Pasternak, 2013 Fejzo (Unexposed control, disease free), 2016
3
0.40
[
0.32
; 0.50]
642
3,095
not evaluable
Ectopic pregnancy
Fejzo (Unexposed control, disease free), 2016
1
1.82
[
0.37
; 8.83]
9
1,070
not evaluable
Elective/induced termination of pregnancy
Fejzo (Unexposed control, disease free), 2016
1
1.10
[
0.71
; 1.70]
86
1,070
not evaluable
Therapeutic terminations of pregnancy
Einarson (Unexposed control), 2004
1
5.06
[
0.24
; 106.12]
2
176
not evaluable
Intrauterine deaths (as a whole or unspecified)
Ozdemirci, 2014
1
0.28
[
0.01
; 6.96]
1
100
not evaluable
Neuro-developmental disorders
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Clements, 2015
1
1.36
[
0.95
; 1.94]
2,243
163
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Clements, 2015
1
1.36
[
0.95
; 1.94]
2,243
163
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Clements, 2015
1
1.39
[
0.97
; 2.00]
1,377
173
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Clements, 2015
1
1.39
[
0.97
; 2.00]
1,377
173
not evaluable
Neuro-developmental disorders (as a whole)
Fejzo, 2015
1
1.34
[
0.82
; 2.17]
138
213
not evaluable
0.0
100.0
1.0