Pregabalin (All indications)

Preterm (< 37 weeks)

id	Study   Auto Dudukina (Controls exposed to LTG) (Mixed indications), 2023Dudukina (Controls unexposed, NOS) (Mixed indications), 2023Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020Coste (Controls unexposed, NOS) (Mixed indications), 2020Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014Kilic (Controls unexposed NOS) (Mixed indications), 2014Kilic (Controls unexposed, sick) (Mixed indications), 2014	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.
S15251 R62708	Dudukina (Controls exposed to LTG) (Mixed indications), 2023	Preterm birth (gestational age <37 weeks)	3 months (or more) before pregnancy or during pregnancy	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: Yes	0.94 [0.79;1.11] excluded (control group)	188/2,414   540/7,243	728	2,414		ref
S15252 R62729	Dudukina (Controls unexposed, NOS) (Mixed indications), 2023	Preterm birth (gestational age <37 weeks)	3 months (or more) before pregnancy or during pregnancy excluded	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes	1.15 [1.00;1.32] excluded (exposition period)	188/2,414   151,114/3,009,386	151,302	2,414		ref
S10100 R36794	Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020	Gestational age at birth (< 37 WA)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No	1.09 [0.85;1.39] C excluded (control group)	110/1,627   182/2,916	292	1,627		ref
S8541 R28338	Coste (Controls unexposed, NOS) (Mixed indications), 2020	Gestational age at birth (< 37 WA)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: No	1.29 [1.06;1.56] C	110/1,627   91,255/1,710,441	91,365	1,627		ref
S8537 R28309	Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Preterm (< 37 weeks)	during pregnancy (anytime or not specified)	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	2.88 [0.78;10.68] C excluded (control group)	3/13   83/880	86	13		ref
S8538 R28312	Kilic (Controls unexposed NOS) (Mixed indications), 2014	Preterm (< 37 weeks)	during pregnancy (anytime or not specified)	population based cohort retrospective	unexposed (general population or NOS) excluded	Adjustment: No	5.68 [1.56;20.63] C excluded (control group)	3/13   33,974/676,834	33,977	13		ref
S8539 R28315	Kilic (Controls unexposed, sick) (Mixed indications), 2014	Preterm (< 37 weeks)	during pregnancy (anytime or not specified)	population based cohort retrospective	unexposed, sick	Adjustment: No Controls: epilepsy indication	3.85 [1.05;14.04] C	3/13   383/5,296	386	13		ref
					Total	2 studies	1.83 [0.67;5.00]		91,751	1,640
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 8537, 8538, 10100, 15251