Pregabalin (All indications)

Microcephaly / Small head circumference for gestational age

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S15251
R62711		 Dudukina (Controls exposed to LTG) (Mixed indications), 2023 Microcephaly (head circumference at birth (cm) smaller than 2 SD of sex- and gestational week specific distribution) 3 months (or more) before pregnancy or during pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: Yes 1.00 [0.68;1.46]
excluded (control group) 		54/2,373   149/7,091 203 2,373
ref
S15252
R62732		 Dudukina (Controls unexposed, NOS) (Mixed indications), 2023 Microcephaly (head circumference at birth (cm) smaller than 2 SD of sex- and gestational week specific distribution) 3 months (or more) before pregnancy or during pregnancy excluded population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.00 [0.76;1.31]
excluded (exposition period) 		54/2,373   56,404/2,940,009 56,458 2,373
ref
S10045
R36362		 Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Controls: mixed indications 0.60 [0.02;14.68] C
excluded (control group) 		0/1,671   1/2,997 1 1,671
ref
S10046
R36385		 Blotière (Controls unexposed NOS) (Other indications), 2019 Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.28 [0.08;20.51] C 0/1,671   438/1,875,733 438 1,671
ref
Total 1 studies 1.28 [0.08;20.51] 438 1,671
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

StudyTE95% CIn casesn exposedweightROBABCDEF Blotière (Controls unexposed NOS) (Other indications), 2019Blotière, 2019 1 1.28[0.08; 20.51]4381,6710%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA0.55.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed NOS) (Other indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.28[0.08; 20.51]4381,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.28[0.08; 20.51]4381,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1 Tags Adjustment   - No  - No 1.28[0.08; 20.51]4381,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1 All studiesAll studies 1.28[0.08; 20.51]4381,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 10.55.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 10045, 15251

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.28[0.08; 20.51]4381,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.60[0.02; 14.68]11,671 -NABlotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 10.510.01.0