Phenytoin (All indications)

Neonatal medical care

id	Study   Auto Aydin (Phenytoin) (Controls exposed to Lamotrigine, sick), 2020Aydin (Phenytoin) (Controls unexposed, sick), 2020Bank (Phenytoin) (Mixed indications), 2017Artama (Phenytoin) (Controls exposed to Lamotrigine, sick), 2013Artama (Phenytoin) (Controls unexposed, disease free), 2013Artama (Phenytoin) (Controls unexposed, sick), 2013Viinikainen (Phenytoin) (Controls unexposed, disease free) a, 2006D'Souza (Phenytoin) (Controls unexposed, disease free), 1991D'Souza (Phenytoin) (Controls unexposed, sick), 1991	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimester	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S9192 R31823	Aydin (Phenytoin) (Controls exposed to Lamotrigine, sick), 2020	Neonatal intensive care unit (NICU)	throughout pregnancy	retrospective cohort	exposed to other treatment, sick excluded	Adjustment: No	3.67 [0.05;274.53] C excluded (control group)	1/1   2/7	3	1		ref
S9193 R31833	Aydin (Phenytoin) (Controls unexposed, sick), 2020	Neonatal intensive care unit (NICU)	throughout pregnancy	retrospective cohort	unexposed, sick	Adjustment: No	13.67 [0.19;964.02] C	1/1   2/22	3	1		ref
S9272 R32154	Bank (Phenytoin) (Mixed indications), 2017	Admission to neonatal intensive care unit (NICU) or Special Care Nursery	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.91 [0.04;21.24] C	0/3   6/36	6	3		ref
S9187 R31771	Artama (Phenytoin) (Controls exposed to Lamotrigine, sick), 2013	Admission to neonatal care unit	3rd trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	0.13 [0.01;2.20] C excluded (control group)	0/21   24/154	24	21		ref
S9188 R31783	Artama (Phenytoin) (Controls unexposed, disease free), 2013	Admission to neonatal care unit	3rd trimester	population based cohort retrospective	unexposed, disease free excluded	Adjustment: No	0.31 [0.02;5.20] C excluded (control group)	0/21   49,612/689,482	49,612	21		ref
S9190 R31807	Artama (Phenytoin) (Controls unexposed, sick), 2013	Admission to neonatal care unit	3rd trimester	population based cohort retrospective	unexposed, sick	Adjustment: No	0.25 [0.01;4.13] C	0/21   152/1,708	152	21		ref
S9219 R31989	Viinikainen (Phenytoin) (Controls unexposed, disease free) a, 2006	Admission to a neonatal unit	throughout pregnancy	prospective cohort	unexposed, disease free	Adjustment: No	4.20 [0.17;103.11] C	0/2   1,822/24,778	1,822	2		ref
S9194 R31864	D'Souza (Phenytoin) (Controls unexposed, disease free), 1991	Idiopathic respiratory distress	throughout pregnancy	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	9.00 [0.35;229.68] C excluded (control group)	1/22   0/62	1	22		ref
S9195 R31893	D'Souza (Phenytoin) (Controls unexposed, sick), 1991	Idiopathic respiratory distress	throughout pregnancy	prospective cohort	unexposed, sick	Adjustment: No	1.10 [0.04;30.00] C	1/22   0/8	1	22		ref
					Total	5 studies	1.25 [0.29;5.38]		1,984	49
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 9194, 9187, 9188, 9192