Gabapentin (Epilepsy)

Major congenital malformations

id	Study   Auto Tomson (Gabapentin), 2018Arkilo (Gabapentin), 2015Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick), 2013Vajda (Gabapentin) (Controls unexposed, sick), 2013Mawer (Gabapentin) (Controls exposed to Lamotrigine, sick), 2010Mawer (Gabapentin) (Controls unexposed, disease free), 2010Mawer (Gabapentin) (Controls unexposed, sick), 2010Morrow (Gabapentin) (Controls exposed to Lamotrigine, sick), 2006Morrow (Gabapentin) (Controls unexposed, sick), 2006Dean (Gabapentin), 2002	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.
S7650 R22628	Tomson (Gabapentin), 2018	Malformed Offspring	at least 1st trimester	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.94 [0.13;6.97] C	1/36   74/2,514	75	36		ref
S6252 R16647	Arkilo (Gabapentin), 2015	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	exposed to other treatment, sick	Adjustment: No	47.00 [0.38;5814.69] C excluded (exposition period)	0/1   0/24	0	1		ref
S6379 R17374	Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick), 2013	Fetal malformations	at least 1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.83 [0.05;14.66] C excluded (control group)	0/14   13/315	13	14		ref
S6370 R17365	Vajda (Gabapentin) (Controls unexposed, sick), 2013	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.95 [0.05;18.18] C	0/14   5/147	5	14		ref
S8274 R26216	Mawer (Gabapentin) (Controls exposed to Lamotrigine, sick), 2010	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	4.60 [0.15;144.69] C excluded (control group)	0/2   2/37	2	2		ref
S8276 R26218	Mawer (Gabapentin) (Controls unexposed, disease free), 2010	Major malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	14.28 [0.53;384.83] C excluded (control group)	0/2   6/285	6	2		ref
S8278 R26220	Mawer (Gabapentin) (Controls unexposed, sick), 2010	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	8.78 [0.24;318.70] C	0/2   1/41	1	2		ref
S6060 R15750	Morrow (Gabapentin) (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.99 [0.13;7.64] C excluded (control group)	1/31   21/647	22	31		ref
S6059 R15749	Morrow (Gabapentin) (Controls unexposed, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.91 [0.11;7.55] C	1/31   8/227	9	31		ref
S6682 R18545	Dean (Gabapentin), 2002	Major congenital malformations	at least 1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	14.20 [0.23;878.06] C	0/1   2/38	2	1		ref
					Total	5 studies	1.48 [0.46;4.79]		92	84
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 6060, 8274, 8276, 6379