metaPreg - Phenytoin (All indications) during pregnancy

Phenytoin (All indications)

Table Graphic exposition period:

Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)	2.08 [1.48, 2.92]	21%	21 studies	49,839	1,586	probable	ROB	3.57 [2.32; .]
Major congenital malformations	1.69 [1.18, 2.41]	12%	15 studies	49,730	1,341	low	ROB	2.76 [1.65; .]
Congenital heart defects	2.10 [0.93, 4.72]	41%	9 studies	65	875	not evaluable	ROB	-
Limb defects	2.20 [0.64, 7.52]	0%	5 studies	14	290	not evaluable	ROB	-
Neural Tube Defects	3.20 [0.89, 11.45]	0%	6 studies	8	694	not evaluable	ROB	-
Microcephaly / Small head circumference for gestational age	0.72 [0.32, 1.63]	0%	6 studies	26	330	not evaluable	ROB	-
Cleft lip with or without cleft palate	5.07 [0.94, 27.30]	0%	5 studies	3	113	not evaluable	ROB	-
Hypospadias	0.75 [0.22, 2.57]	0%	5 studies	18	666	serious	ROB	-
Polydactyly	2.60 [0.22, 30.36]	45%	4 studies	3	168	not evaluable	ROB	-
Minor congenital malformations	2.46 [1.09, 5.57]	26%	4 studies	71	106	not evaluable	ROB	4.36 [1.40; .]
Spina bifida	3.70 [0.29, 47.79]	46%	4 studies	2	101	not evaluable	ROB	-
Urinary malformations	1.17 [0.16, 8.76]	27%	3 studies	15	282	not evaluable	ROB	-
Digestive system anomalies	1.88 [0.29, 12.03]	0%	2 studies	5	201	not evaluable	ROB	-
Oro-facial clefts	1.91 [0.55, 6.62]	0%	3 studies	14	623	not evaluable	ROB	-
Cleft palate	4.13 [0.07, 229.95]	48%	2 studies	1	22	not evaluable	ROB	-
Eye defects	1.75 [0.31, 9.77]	24%	2 studies	11	62	not evaluable	ROB	-
8 non statistically significant endpoints reported in only one study
Growth parameters and prematurity
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Preterm (< 37 weeks)	2.14 [0.99, 4.62]	0%	7 studies	491	108	not evaluable	ROB	-
Small for gestational age (weight)	1.20 [0.40, 3.58]	0%	6 studies	646	112	not evaluable	ROB	-
Low birth weight (< 2500g)	2.12 [0.43, 10.42]	12%	2 studies	316	31	not evaluable	ROB	-
Large for gestational age (weight)	3.81 [0.42, 34.93]	25%	2 studies	74	27	not evaluable	ROB	-
1 non statistically significant endpoints reported in only one study
Maternal consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Gestational diabetes	2.30 [0.67, 7.91]	0%	2 studies	11	53	not evaluable	ROB	-
Preeclampsia	3.28 [0.13, 84.58]	50%	2 studies	8	53	not evaluable	ROB	-
2 non statistically significant endpoints reported in only one study
Neonatal disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Neonatal medical care	1.25 [0.29, 5.38]	0%	5 studies	1,984	49	not evaluable	ROB	-
Low Apgar score (< 7) (at 1 min)	3.53 [1.15, 10.87]	4%	3 studies	85	77	not evaluable	ROB	6.52 [1.55; .]
Low Apgar score (< 7) (at 5 min)	20.01 [2.75, 145.51]	0%	3 studies	5	58	not evaluable	ROB	39.51 [4.95; .]
Feeding difficulty	1.79 [0.18, 18.25]	0%	2 studies	2	34	not evaluable	ROB	-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation	-	-	0 study					-
6 non statistically significant endpoints reported in only one study
Long term consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
5 non statistically significant endpoints reported in only one study
Intrauterine deaths
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Intrauterine deaths (as a whole or unspecified)	4.81 [1.66, 13.92]	0%	5 studies	21	233	not evaluable	ROB	9.09 [2.71; .]
Early intrauterine death (< 22 weeks)	1.73 [0.12, 25.30]	0%	2 studies	2	6	not evaluable	ROB	-
Perinatal death	2.05 [0.20, 20.82]	0%	2 studies	10	57	not evaluable	ROB	-
Late intrauterine deaths (> 22 weeks)	12.49 [0.56, 277.13]	0%	2 studies		6	not evaluable	ROB	-
2 non statistically significant endpoints reported in only one study
Neuro-developmental disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Cognitive developmental disorders/delay (> 6 years old)	1.11 [0.49, 2.53]	45%	5 studies	5	123	not evaluable	ROB	-
Language disorders/delay	0.99 [0.61, 1.63]	0%	4 studies	6	111	not evaluable	ROB	-
Neuro-developmental disorders (as a whole)	2.37 [0.65, 8.62]	47%	4 studies	51	57	not evaluable	ROB	-
Cognitive developmental disorders/delay (< 3 years old)	1.17 [0.40, 3.49]	66%	4 studies	52	133	not evaluable	ROB	-
Psychomotor developmental disorders/delay	0.60 [0.32, 1.12]	0%	3 studies	19	71	not evaluable	ROB	-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)	0.68 [0.05, 8.52]	0%	2 studies	1	52	not evaluable	ROB	-
12 non statistically significant endpoints reported in only one study