Triptans

All congenital malformations (majors, minors, majors and minors, or unspecified)

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.
S3510
R6883
Spielmann (Control mainly exposed other treatments, sick), 2017 All birth defects 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 1.14 [0.65;2.00] C
excluded (control group)
24/328   28/431 52 328
ref
S3509
R6859
Spielmann (Control unexposed, disease free), 2017 All birth defects 1st trimester prospective cohort unexposed, disease free Adjustment: No 1.20 [0.75;1.91] C 24/328   95/1,538 119 328
ref
S3492
R6763
Nezvalová-Henriksen (Control unexposed, disease free), 2013 Congenital malformations (any) 1st trimester population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 1.13 [0.89;1.44]
excluded (control group)
72/1,210   9,136/178,565 9,208 1,210
ref
S851
R6745
Nezvalová-Henriksen (Control unexposed, sick), 2013 Congenital malformations (any) 1st trimester population based cohort retrospective unexposed, sick Adjustment: No 0.97 [0.69;1.37] C 72/1,210   67/1,095 139 1,210
ref
S850
R11398
Bérard, 2012 Major congenital malformations during pregnancy (anytime or not specified) excluded nested case control unexposed, disease free Adjustment: Yes 1.49 [0.89;2.52]
excluded (exposition period)
18/139   4,698/59,568 4,716 139
ref
S3494
R6812
Källén (control exposed to ergots), 2011 Any congenital malformations 1st trimester population based cohort propective exposed to other treatment, sick excluded Adjustment: No 1.15 [0.72;1.85] C
excluded (control group)
127/2,777   21/527 148 2,777
ref
S849
R6557
Källén (control unexposed, disease free), 2011 Any congenital malformations 1st trimester population based cohort propective unexposed, disease free Adjustment: Yes 0.97 [0.81;1.16] 127/2,777   56,759/1,229,901 56,886 2,777
ref
S3595
R11396
Shuhaiber - Sumatriptan (Control exposed to other treatments), 1998 Major congenital malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 1.10 [0.07;17.86] C
excluded (control group)
1/82   1/90 2 82
ref
S3596
R11397
Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 Major congenital malformations at least 1st trimester prospective cohort unexposed, disease free Adjustment: No 1.11 [0.07;18.06] C 1/82   1/91 2 82
ref
Total 4 studies 0.99 [0.85;1.15] 57,146 4,397
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 Spielmann (Control unexposed, disease free), 2017Spielmann, 2017 1 1.20[0.75; 1.91]11932810%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Nezvalová-Henriksen (Control unexposed, sick), 2013Nezvalová-Henriksen, 2013 2 0.97[0.69; 1.37]1391,21019%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Källén (control unexposed, disease free), 2011Källén, 2011 3 0.97[0.81; 1.16]56,8862,77770%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998Shuhaiber - Sumatriptan, 1998 4 1.11[0.07; 18.06]2820%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 0.99[0.85; 1.15]57,1464,3970.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Control unexposed, disease free; 2: Control unexposed, sick; 3: control unexposed, disease free; 4: Control unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.99[0.85; 1.15]57,1464,3970%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.00[0.84; 1.18]57,0073,1870%NASpielmann (Control unexposed, disease free), 2017 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 3 unexposed, sickunexposed, sick 0.97[0.69; 1.37]1391,210 -NANezvalová-Henriksen (Control unexposed, sick), 2013 1 Tags Adjustment   - No  - No 1.05[0.80; 1.38]2601,6200%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, sick), 2013 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 3   - Yes  - Yes 0.97[0.81; 1.16]56,8862,777 -NAKällén (control unexposed, disease free), 2011 1 All studiesAll studies 0.99[0.85; 1.15]57,1464,3970%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.33.31.7070.000Spielmann (Control unexposed, disease free), 2017Nezvalová-Henriksen (Control unexposed, sick), 2013Källén (control unexposed, disease free), 2011Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998

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 3595, 3494, 3492, 3510

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.04[0.91; 1.19]66,2154,3970%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, disease free), 2013 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 4 unexposed, sick controlsunexposed, sick controls 0.97[0.69; 1.37]1391,210 -NANezvalová-Henriksen (Control unexposed, sick), 2013 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.15[0.80; 1.64]2023,1870%NASpielmann (Control mainly exposed other treatments, sick), 2017 Källén (control exposed to ergots), 2011 Shuhaiber - Sumatriptan (Control exposed to other treatments), 1998 30.510.01.0