Miconazole (local route only)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Daniel, 2018 Israel
2003 - 2009
All clinically apparent pregnancies to women 15-45 years of age registered with Clalit Health Services (CHS) maintenance organization who were admitted for birth or diagnosed with spontaneous abortion at Soroka Medical Center (SMC). Dispensation of vaginal miconazole from the first day of the last menstrual period until the date of admission to the hospital for pregnancies that resulted in spontaneous abortion or until 20 weeks of pregnancy for pregnancies that ended with birth. unexposed (general population or NOS)
No dispensation of anti-mycotic medication (vaginal or oral).
633 / 62137 Vaginal exposure.
Rotem, 2018 Israel
1999 - 2009
All women who gave birth or underwent a pregnancy termination at Soroka Medical Center, Beer-Sheva, Israel. Women who were dispensed with miconazole vaginal tablets during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnancies that were not exposed to either drug from the azoles family (e.g. vaginal, systemic or topical formulation).
313 / 95781 Vaginal exposure

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Kazy, 2005 Hungary
1980 - 1996
Infants (liveborn infants, stillborn infants, and electively aborted fetuses) with congenital abnormalities (CAs) were selected from the Hungarian Congenital Abnormality Registry. Infants without congenital abnormalities, matched according to sex, birth week, and district of parents' residence selected from the national birth registry of the Central Statistical Office. 22843 / 38151 Three 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 were excluded.

master protocol