Clotrimazole updated on 01-29-2025

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.
S17541
R73859		 Rotem, 2018 Major malformations 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Route of exposure Azoles: Vaginal 1.11 [0.93;1.33] 134/1,993   5,777/95,781 5,911 1,993
ref
S17539
R73847		 Czeizel, 1999 Congenital abnormalities (excluding infants with three mild defects (congenital dislocation of hip based on Ortolani click, congenital inguinal hernia, and hemangiomas), syndromes of known origin (eg, chromosome disorders), and minor anomalies) 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Matched Route of exposure Azoles: Local (NOS) 0.95 [0.79;1.14] 253/751   18,262/50,568 18,515 751
ref
S17537
R73822		 Rosa, 1987 Birth defects 1st trimester case control unexposed (general population or NOS) Adjustment: No Route of exposure Azoles: Local (NOS) 1.09 [0.90;1.40] 74/1,086   6,490/103,253 6,564 1,086
ref
Total 3 studies 1.04 [0.93;1.17] 30,990 3,830
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 Rotem, 2018Rotem, 2018 1.11[0.93; 1.33]5,9111,99338%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Czeizel, 1999Czeizel, 1999 0.95[0.79; 1.14]18,51575136%ROB confusion: unclearROB selection: criticalROB classification: moderateROB missing: moderateROB mesure: criticalROB reporting: moderate Rosa, 1987Rosa, 1987 1.09[0.90; 1.40]6,5641,08625%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Total (3 studies) I2 = 0% 1.04[0.93; 1.17]30,9903,8300.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.11[0.93; 1.33]5,9111,993 -NARotem, 2018 1 case control studiescase control studies 1.00[0.87; 1.16]25,0791,8370%NACzeizel, 1999 Rosa, 1987 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.04[0.93; 1.17]30,9903,8300%NARotem, 2018 Czeizel, 1999 Rosa, 1987 3 Tags Adjustment   - No  - No 1.09[0.87; 1.36]6,5641,086 -NARosa, 1987 1   - Yes  - Yes 1.03[0.88; 1.20]24,4262,74429%NARotem, 2018 Czeizel, 1999 2 MatchedMatched 0.95[0.79; 1.14]18,515751 -NACzeizel, 1999 1 Route of exposure Azoles   - Local (NOS)  - Local (NOS) 1.00[0.87; 1.16]25,0791,8370%NACzeizel, 1999 Rosa, 1987 2   - Vaginal  - Vaginal 1.11[0.93; 1.33]5,9111,993 -NARotem, 2018 1 All studiesAll studies 1.04[0.93; 1.17]30,9903,8300%NARotem, 2018 Czeizel, 1999 Rosa, 1987 30.25.01.0

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.04[0.93; 1.17]30,9903,8300%NARotem, 2018 Czeizel, 1999 Rosa, 1987 30.510.01.0