Miconazole (local route only) updated on 01-29-2025

Major congenital malformations

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.
S17578
R74143		 Rotem, 2018 Major malformations 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Route of exposure Azoles: Vaginal 1.46 [0.99;2.15] 28/313   5,777/95,781 5,805 313
ref
S17577
R74120		 Kazy, 2005 Congenital abnormalities (excluding 3 mild CAs (such as congenital dislocation of the hip based on the Ortolani click, congenital inguinal hernia and hemangiomas), minor variants (e.g., umbilical hernia) and CA-syndromes of Mendelian and chromosomal origin) 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Co-administration Matched Route of exposure Azoles: Vaginal 1.20 [0.90;1.50] 152/355   22,691/60,639 22,843 355
ref
Total 2 studies 1.27 [1.03;1.58] 28,648 668
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 1.46[0.99; 2.15]5,80531330%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Kazy, 2005Kazy, 2005 1.20[0.90; 1.50]22,84335570%ROB confusion: unclearROB selection: criticalROB classification: moderateROB missing: moderateROB mesure: criticalROB reporting: moderate Total (2 studies) I2 = 0% 1.27[1.03; 1.58]28,6486680.55.01.0ROB: 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 1.46[0.99; 2.15]5,805313 -NARotem, 2018 1 case control studiescase control studies 1.20[0.93; 1.55]22,843355 -NAKazy, 2005 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.27[1.03; 1.58]28,6486680%NARotem, 2018 Kazy, 2005 2 Tags Adjustment   - Yes  - Yes 1.27[1.03; 1.58]28,6486680%NARotem, 2018 Kazy, 2005 2 Co-administrationCo-administration 1.20[0.93; 1.55]22,843355 -NAKazy, 2005 1 MatchedMatched 1.20[0.93; 1.55]22,843355 -NAKazy, 2005 1 Route of exposure Azoles   - Vaginal  - Vaginal 1.27[1.03; 1.58]28,6486680%NARotem, 2018 Kazy, 2005 2 All studiesAll studies 1.27[1.03; 1.58]28,6486680%NARotem, 2018 Kazy, 2005 20.55.01.0

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.27[1.03; 1.58]28,6486680%NARotem, 2018 Kazy, 2005 20.510.01.0