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Olanzapine
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)
McKenna, 2005 Peng, 2013 Källen, 2013 Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023 Viguera, 2023 Chan (Controls unexposed, sick), 2024
7
1.17
[
0.98
; 1.39]
30,858
3,534
not evaluable
Major congenital malformations
McKenna, 2005 Peng, 2013 Källen, 2013 Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023 Viguera, 2023 Chan (Controls unexposed, sick), 2024
7
1.17
[
0.98
; 1.39]
30,858
3,534
not evaluable
Congenital heart defects
Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024
2
1.09
[
0.78
; 1.52]
137
2,442
not evaluable
Ano-rectal atresia and stenosis
Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023
2
2.44
[
0.85
; 6.96]
574
3,111
not evaluable
Microcephaly / Small head circumference for gestational age
Boden (Control unexposed, NOS), 2012 Raguideau, 2017
2
0.77
[
0.26
; 2.28]
474
956
not evaluable
Digestive system anomalies
Ellfolk (Controls unexposed NOS), 2021
1
4.33
[
0.63
; 29.68]
47
413
not evaluable
Hip dislocation and/or dysplasia
Huybrechts (Controls unexposed, sick), 2023
1
0.36
[
0.05
; 2.57]
-
2,341
not evaluable
Hydrocephaly
Huybrechts (Controls unexposed, sick), 2023
1
0.30
[
0.04
; 2.19]
-
2,341
not evaluable
Limb defects
Ellfolk (Controls unexposed NOS), 2021
1
3.71
[
1.36
; 10.15]
242
413
not evaluable
Limb reduction defects (LRD)
Huybrechts (Controls unexposed, sick), 2023
1
2.26
[
0.32
; 16.00]
-
2,341
not evaluable
Nervous system anomalies
Ellfolk (Controls unexposed NOS), 2021
1
1.00
[
0.08
; 12.55]
49
413
not evaluable
Oro-facial clefts
Huybrechts (Controls unexposed, sick), 2023
1
2.56
[
1.22
; 5.38]
-
2,341
not evaluable
Respiratory system anomalies
Ellfolk (Controls unexposed NOS), 2021
1
1.43
[
0.04
; 48.60]
21
413
not evaluable
Atrial septal defect
Raguideau, 2017
1
1.40
[
0.28
; 7.00]
3,584
770
not evaluable
Bilateral renal agenesis including Potter syndrome
Raguideau, 2017
1
16.25
[
1.01
; 262.42]
75
770
not evaluable
Bladder exstrophy and/or epispadia
Raguideau, 2017
1
14.87
[
0.92
; 239.97]
82
770
not evaluable
Cleft lip with or without cleft palate
Raguideau, 2017
1
2.90
[
0.56
; 15.00]
1,677
770
not evaluable
Cleft palate
Raguideau, 2017
1
1.00
[
0.06
; 16.07]
1,221
770
not evaluable
Club foot / Talipes equinovarus
Raguideau, 2017
1
2.90
[
0.56
; 14.93]
1,696
770
not evaluable
Coarctation of aorta
Raguideau, 2017
1
1.49
[
0.09
; 23.79]
825
770
not evaluable
Craniosynostosis
Raguideau, 2017
1
1.58
[
0.10
; 25.23]
778
770
not evaluable
Diaphragmatic hernia
Raguideau, 2017
1
3.11
[
0.19
; 49.84]
394
770
not evaluable
Ebstein's anomaly
Raguideau, 2017
1
23.37
[
1.44
; 378.91]
52
770
not evaluable
Gastroschisis
Raguideau, 2017
1
4.98
[
0.31
; 79.86]
246
770
not evaluable
Hypoplastic left heart (HLH/HLHS)
Raguideau, 2017
1
5.17
[
0.32
; 82.90]
237
770
not evaluable
Hypoplastic right heart (HRH/HRHS)
Raguideau, 2017
1
16.92
[
1.05
; 273.39]
72
770
not evaluable
Hypospadias
Raguideau, 2017
1
-
-
-
-
-
Multicystic renal dysplasia
Raguideau, 2017
1
1.77
[
0.11
; 28.33]
693
770
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Raguideau, 2017
1
2.93
[
0.18
; 46.98]
418
770
not evaluable
Omphalocele
Raguideau, 2017
1
4.33
[
0.27
; 69.41]
283
770
not evaluable
Polydactyly
Raguideau, 2017
1
3.16
[
0.20
; 50.62]
388
770
not evaluable
Pulmonary artery atresia
Raguideau, 2017
1
7.64
[
0.48
; 122.84]
160
770
not evaluable
Spina bifida
Raguideau, 2017
1
3.90
[
0.26
; 57.98]
625
770
not evaluable
Tetralogy of Fallot
Raguideau, 2017
1
1.90
[
0.12
; 30.48]
644
770
not evaluable
Transposition of the great vessels
Raguideau, 2017
1
2.24
[
0.14
; 35.83]
548
770
not evaluable
Ventricular septal defect
Raguideau, 2017
1
1.00
[
0.17
; 6.00]
5,011
770
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Newport, 2007 Boden (Control unexposed, NOS), 2012 Vigod, 2015 Ozturk, 2016
4
1.28
[
0.77
; 2.11]
184
354
not evaluable
Small for gestational age (weight)
Boden (Control unexposed, NOS), 2012 Vigod, 2015
2
1.71
[
1.07
; 2.72]
65
353
not evaluable
Large for gestational age (length)
Boden (Control unexposed, NOS), 2012
1
1.94
[
0.87
; 4.33]
-
186
not evaluable
Large for gestational age (weight)
Boden (Control unexposed, NOS), 2012
1
0.55
[
0.14
; 2.14]
-
187
not evaluable
Large head circumference for gestational age
Boden (Control unexposed, NOS), 2012
1
3.02
[
1.60
; 5.71]
2
186
not evaluable
Small for gestational age (length)
Boden (Control unexposed, NOS), 2012
1
1.17
[
0.54
; 2.54]
-
186
not evaluable
Low birth weight (< 2500g)
Newport, 2007
1
11.84
[
0.57
; 247.85]
4
14
not evaluable
Macrosomia (> 4000g)
Newport, 2007
1
0.92
[
0.05
; 16.46]
2
14
not evaluable
Maternal consequences
Gestational diabetes
Boden (Control unexposed, NOS), 2012 Vigod, 2015 Park, 2018 Wang - HK cohort, 2021 Wang - UK cohort, 2021
5
1.53
[
1.17
; 2.00]
6,209
719
not evaluable
Preeclampsia
Vigod, 2015
1
1.03
[
0.45
; 2.32]
49
166
not evaluable
Neonatal disorders
Neonatal disorders (as a whole)
Habermann (Unexposed control), 2013
1
4.02
[
2.07
; 7.81]
56
86
not evaluable
Infant health status
Wurtz, 2017
1
1.01
[
0.91
; 1.12]
-
-
not evaluable
Neonatal death (< 28 days of life)
Källen, 2013
1
1.19
[
0.77
; 1.84]
-
101
not evaluable
Neonatal medical care
Newport, 2007
1
11.84
[
0.57
; 247.85]
4
14
not evaluable
Intrauterine deaths
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions
Sorensen, 2015 Ozturk, 2016 Ishikawa, 2024
3
1.00
[
0.80
; 1.25]
158,486
403
not evaluable
Elective/induced termination of pregnancy
Ozturk, 2016
1
2.00
[
0.10
; 38.88]
14
5
not evaluable
Neuro-developmental disorders
Cognitive developmental disorders/delay (> 6 years old)
Straub, 2022 Bruno, 2024
2
0.80
[
0.35
; 1.85]
4,215
2,727
not evaluable
Language disorders/delay
Straub, 2022 Bruno, 2024
2
0.92
[
0.73
; 1.16]
78,524
2,676
not evaluable
Learning disorders
Straub, 2022 Bruno, 2024
2
0.70
[
0.38
; 1.29]
6,790
1,181
not evaluable
Neuro-developmental disorders (as a whole)
Straub, 2022 Bruno, 2024
2
0.93
[
0.80
; 1.09]
160,370
2,895
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Straub, 2022 Bruno, 2024
2
0.80
[
0.35
; 1.85]
4,215
2,727
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Straub, 2022
1
0.98
[
0.78
; 1.24]
62,455
1,495
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Straub, 2022
1
0.98
[
0.78
; 1.24]
62,455
1,495
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Straub, 2022
1
1.00
[
0.60
; 1.68]
9,617
1,327
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Straub, 2022
1
1.00
[
0.60
; 1.68]
9,617
1,327
not evaluable
Psychomotor developmental disorders/delay
Straub, 2022
1
0.89
[
0.40
; 2.00]
8,221
1,327
not evaluable
0.0
100.0
1.0