Gabapentin (All indications)

Preterm (< 37 weeks)

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.
S10095
R36744		 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 2.08 [1.48;2.93] C
excluded (control group) 		46/378   182/2,916 228 378
ref
S8517
R28087		 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 2.46 [1.81;3.35] C 46/378   91,255/1,710,441 91,301 378
ref
S8490
R27880		 Miškov (Controls exposed to Lamotrigine, sick), 2016 Premature deliveries during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 12.00 [0.53;273.05] C
excluded (control group) 		1/2   2/26 3 2
ref
S8491
R27885		 Miškov (Controls unexposed, disease free), 2016 Premature deliveries during pregnancy (anytime or not specified) prospective cohort unexposed, disease free excluded Adjustment: No 31.00 [1.63;589.49] C
excluded (control group) 		1/2   4/128 5 2
ref
S8492
R27891		 Miškov (Controls unexposed, sick), 2016 Premature deliveries during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No 21.00 [0.27;1646.32] C 1/2   0/4 1 2
ref
S8485
R27852		 Arkilo, 2015 Premature delivery during pregnancy (anytime or not specified) retrospective cohort exposed to other treatment, sick Adjustment: No 5.86 [0.10;346.64] C 0/1   3/24 3 1
ref
S8513
R28058		 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 1.37 [0.66;2.86] C
excluded (control group) 		9/72   83/880 92 72
ref
S8514
R28061		 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 2.50 [1.40;4.60]
excluded (control group) 		9/72   33,974/676,834 33,983 72
ref
S8515
R28064		 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 1.83 [0.90;3.71] C 9/72   383/5,296 392 72
ref
Total 4 studies 2.38 [1.79;3.15] 91,697 453
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 Coste (Controls unexposed, NOS) (Mixed indications), 2020Coste, 2020 1 2.46[1.81; 3.35]91,30137883%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Miškov (Controls unexposed, sick), 2016Miškov, 2016 2 21.00[0.27; 1646.32]120%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: criticalROB mesure: moderateROB reporting: moderate Arkilo, 2015Arkilo, 2015 5.86[0.10; 346.64]310%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Kilic (Controls unexposed, sick) (Mixed indications), 2014Kilic, 2014 3 1.83[0.90; 3.71]3927216%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 0% 2.38[1.79; 3.15]91,6974530.550.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, NOS) (Mixed indications; 2: Controls unexposed, sick; 3: Controls unexposed, sick) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.38[1.79; 3.15]91,6974530%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Miškov (Controls unexposed, sick), 2016 Arkilo, 2015 Kilic (Controls unexposed, sick) (Mixed indications), 2014 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.46[1.81; 3.35]91,301378 -NACoste (Controls unexposed, NOS) (Mixed indications), 2020 1 unexposed, sickunexposed, sick 2.31[0.57; 9.35]3937415%NAMiškov (Controls unexposed, sick), 2016 Kilic (Controls unexposed, sick) (Mixed indications), 2014 2 exposed to other treatment, sickexposed to other treatment, sick 5.86[0.10; 346.64]31 -NAArkilo, 2015 1 Tags Adjustment   - No  - No 2.38[1.79; 3.15]91,6974530%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Miškov (Controls unexposed, sick), 2016 Arkilo, 2015 Kilic (Controls unexposed, sick) (Mixed indications), 2014 4 Controls   - epilepsy indication  - epilepsy indication 1.83[0.90; 3.71]39272 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 2.38[1.79; 3.15]91,6974530%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Miškov (Controls unexposed, sick), 2016 Arkilo, 2015 Kilic (Controls unexposed, sick) (Mixed indications), 2014 40.550.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-5.26.12.6700.000Coste (Controls unexposed, NOS) (Mixed indications), 2020Miškov (Controls unexposed, sick), 2016Arkilo, 2015Kilic (Controls unexposed, sick) (Mixed indications), 2014

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 8513, 8514, 8490, 8491, 10095

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.60[1.71; 3.95]125,28945229%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Miškov (Controls unexposed, disease free), 2016 Kilic (Controls unexposed NOS) (Mixed indications), 2014 3 unexposed, sick controlsunexposed, sick controls 2.31[0.57; 9.35]3937415%NAMiškov (Controls unexposed, sick), 2016 Kilic (Controls unexposed, sick) (Mixed indications), 2014 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.98[1.45; 2.69]3264530%NACoste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 Miškov (Controls exposed to Lamotrigine, sick), 2016 Arkilo, 2015 Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 40.510.01.0