Primidone AND Phenobarbital (Epilepsy) updated on 04-22-2025

Preterm (< 37 weeks)

id	Study   Auto Leite (Phenobarbital), 2024Coste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2020Coste (Phenobarbital) (Controls unexposed, NOS), 2020Endo (Phenobarbital) (Controls unexposed, disease free), 2004Endo (Phenobarbital) (Controls unexposed, sick), 2004Koch (Phenobarbital or Primidone), 1996Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991Van der Pol (Phenobarbital) (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 specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S18082 R76134	Leite (Phenobarbital), 2024	Premature Delivery <37weeks	during pregnancy (anytime or not specified)	retrospective cohort	unexposed, disease free	Adjustment: No	0.60 [0.24;1.48]	-/70   98/492	-	70		ref
S8704 R29339	Coste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 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 Controls: mixed indications	0.95 [0.38;2.39] C excluded (control group)	5/84   175/2,813	180	84		ref
S8705 R29357	Coste (Phenobarbital) (Controls unexposed, NOS), 2020	Gestational age at birth (< 37 WA)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: No	1.12 [0.45;2.77] C	5/84   91,255/1,710,441	91,260	84		ref
S8653 R29125	Endo (Phenobarbital) (Controls unexposed, disease free), 2004	Preterm delivery (< week 37)	throughout pregnancy	retrospective cohort	unexposed, disease free excluded	Adjustment: No	0.59 [0.07;4.70] C excluded (control group)	1/10   104/656	105	10		ref
S8654 R29140	Endo (Phenobarbital) (Controls unexposed, sick), 2004	Preterm delivery (< week 37)	throughout pregnancy	retrospective cohort	unexposed, sick	Adjustment: No	0.18 [0.00;12.84] C	1/10   0/1	1	10		ref
S8711 R29401	Koch (Phenobarbital or Primidone), 1996	Prematurity (< 37 weeks)	during pregnancy (anytime or not specified)	prospective cohort	unexposed (general population or NOS)	Adjustment: No Matched	18.29 [1.90;176.35] C	4/18   1/65	5	18		ref
S8714 R29416	Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991	Gestational age (≤ 37 wk)	throughout pregnancy	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	1.16 [0.12;11.40] C excluded (control group)	1/12   4/55	5	12		ref
S8715 R29441	Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991	Gestational age (≤ 37 wk)	throughout pregnancy	prospective cohort	unexposed, sick	Adjustment: No	0.91 [0.07;11.19] C	1/12   2/22	3	12		ref
					Total	5 studies	1.20 [0.42;3.41]		91,269	194
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 8714, 8653, 8704