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Risperidone Paliperidone
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)
Reis (Unexposed control, NOS), 2008 Shechtman (Unexposed control), 2009 Peng, 2013 Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024
6
1.34
[
1.13
; 1.59]
61,530
2,999
not evaluable
Major congenital malformations
Reis (Unexposed control, NOS), 2008 Shechtman (Unexposed control), 2009 Peng, 2013 Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024
6
1.34
[
1.13
; 1.59]
61,530
2,999
not evaluable
Congenital heart defects
Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024
2
0.99
[
0.67
; 1.47]
136
2,319
not evaluable
Ano-rectal atresia and stenosis
Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023
2
1.82
[
0.52
; 6.29]
574
2,777
not evaluable
Gastroschisis
Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023
2
2.32
[
0.67
; 8.04]
246
2,777
not evaluable
Digestive system anomalies
Ellfolk (Controls unexposed NOS), 2021
1
1.19
[
0.08
; 17.85]
46
242
not evaluable
Hip dislocation and/or dysplasia
Huybrechts (Controls unexposed, sick), 2023
1
1.21
[
0.39
; 3.75]
-
2,270
not evaluable
Hydrocephaly
Huybrechts (Controls unexposed, sick), 2023
1
2.16
[
0.81
; 5.75]
-
2,270
not evaluable
Limb defects
Ellfolk (Controls unexposed NOS), 2021
1
2.77
[
0.92
; 8.32]
238
242
not evaluable
Limb reduction defects (LRD)
Huybrechts (Controls unexposed, sick), 2023
1
4.01
[
1.00
; 16.06]
-
2,270
not evaluable
Nervous system anomalies
Ellfolk (Controls unexposed NOS), 2021
1
1.00
[
0.06
; 16.18]
48
242
not evaluable
Neural Tube Defects
Huybrechts (Controls unexposed, sick), 2023
1
1.86
[
0.26
; 13.26]
-
2,270
not evaluable
Oro-facial clefts
Huybrechts (Controls unexposed, sick), 2023
1
0.85
[
0.27
; 2.65]
-
2,270
not evaluable
Respiratory system anomalies
Ellfolk (Controls unexposed NOS), 2021
1
2.27
[
0.14
; 37.71]
20
242
not evaluable
Atrial septal defect
Raguideau, 2017
1
5.50
[
2.43
; 12.45]
3,588
507
not evaluable
Bilateral renal agenesis including Potter syndrome
Raguideau, 2017
1
24.69
[
1.53
; 398.87]
75
507
not evaluable
Bladder exstrophy and/or epispadia
Raguideau, 2017
1
22.59
[
1.40
; 364.74]
82
507
not evaluable
Cleft lip with or without cleft palate
Raguideau, 2017
1
1.11
[
0.07
; 17.80]
1,675
507
not evaluable
Cleft palate
Raguideau, 2017
1
3.10
[
0.24
; 40.77]
1,222
507
not evaluable
Club foot / Talipes equinovarus
Raguideau, 2017
1
4.40
[
0.77
; 25.05]
1,696
507
not evaluable
Coarctation of aorta
Raguideau, 2017
1
2.26
[
0.14
; 36.16]
825
507
not evaluable
Craniosynostosis
Raguideau, 2017
1
2.39
[
0.15
; 38.35]
778
507
not evaluable
Diaphragmatic hernia
Raguideau, 2017
1
4.72
[
0.29
; 75.76]
394
507
not evaluable
Ebstein's anomaly
Raguideau, 2017
1
35.50
[
2.19
; 575.92]
52
507
not evaluable
Hypoplastic left heart (HLH/HLHS)
Raguideau, 2017
1
7.85
[
0.49
; 126.00]
237
507
not evaluable
Hypoplastic right heart (HRH/HRHS)
Raguideau, 2017
1
25.71
[
1.59
; 415.53]
72
507
not evaluable
Hypospadias
Raguideau, 2017
1
2.20
[
0.43
; 11.29]
3,406
507
not evaluable
Microcephaly / Small head circumference for gestational age
Raguideau, 2017
1
7.80
[
0.53
; 115.56]
475
507
not evaluable
Multicystic renal dysplasia
Raguideau, 2017
1
2.69
[
0.17
; 43.06]
693
507
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Raguideau, 2017
1
4.45
[
0.28
; 71.41]
418
507
not evaluable
Omphalocele
Raguideau, 2017
1
6.57
[
0.41
; 105.50]
283
507
not evaluable
Polydactyly
Raguideau, 2017
1
4.80
[
0.30
; 76.93]
388
507
not evaluable
Pulmonary artery atresia
Raguideau, 2017
1
11.61
[
0.72
; 186.72]
160
507
not evaluable
Spina bifida
Raguideau, 2017
1
2.98
[
0.19
; 47.82]
624
507
not evaluable
Tetralogy of Fallot
Raguideau, 2017
1
2.89
[
0.18
; 46.34]
644
507
not evaluable
Transposition of the great vessels
Raguideau, 2017
1
3.40
[
0.21
; 54.46]
548
507
not evaluable
Ventricular septal defect
Raguideau, 2017
1
-
-
-
-
-
Growth parameters and prematurity
Preterm (< 37 weeks)
Newport, 2007 Vigod, 2015 Ozturk, 2016
3
1.02
[
0.57
; 1.83]
169
120
not evaluable
Low birth weight (< 2500g)
Newport, 2007
1
8.33
[
0.28
; 244.06]
1
6
not evaluable
Macrosomia (> 4000g)
Newport, 2007
1
0.70
[
0.02
; 20.03]
1
6
not evaluable
Maternal consequences
Gestational diabetes
Vigod, 2015 Park, 2018 Wang - HK cohort, 2021
3
1.03
[
0.70
; 1.51]
183
471
not evaluable
Preeclampsia
Vigod, 2015
1
1.55
[
0.68
; 3.55]
49
112
not evaluable
Neonatal disorders
Neonatal medical care
Newport, 2007
1
2.27
[
0.04
; 129.96]
-
6
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
Shechtman (Control exposed to Haloperidol), 2009
1
1.68
[
0.48
; 5.90]
12
71
not evaluable
Intrauterine deaths
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions
Yaris, 2005 Sorensen, 2015 Ozturk, 2016 Ishikawa, 2024
4
1.31
[
0.72
; 2.38]
158,481
232
not evaluable
Elective/induced termination of pregnancy
Shechtman (Unexposed control), 2009 Ozturk, 2016
2
4.57
[
1.41
; 14.77]
24
108
not evaluable
Neuro-developmental disorders
Cognitive developmental disorders/delay (> 6 years old)
Straub, 2022 Bruno, 2024
2
1.45
[
0.71
; 3.00]
4,199
1,603
not evaluable
Language disorders/delay
Straub, 2022 Bruno, 2024
2
0.87
[
0.66
; 1.15]
58,202
1,603
not evaluable
Learning disorders
Straub, 2022 Bruno, 2024
2
0.88
[
0.27
; 2.91]
6,775
294
not evaluable
Neuro-developmental disorders (as a whole)
Straub, 2022 Bruno, 2024
2
0.95
[
0.69
; 1.31]
160,332
1,698
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Straub, 2022 Bruno, 2024
2
1.45
[
0.71
; 3.00]
4,199
1,603
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Straub, 2022
1
1.01
[
0.78
; 1.30]
62,437
1,404
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Straub, 2022
1
1.01
[
0.78
; 1.30]
62,437
1,404
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Straub, 2022
1
0.62
[
0.31
; 1.24]
9,591
1,309
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Straub, 2022
1
0.62
[
0.31
; 1.24]
9,591
1,309
not evaluable
Psychomotor developmental disorders/delay
Straub, 2022
1
1.44
[
0.77
; 2.69]
8,241
1,309
not evaluable
0.0
100.0
1.0