Background
Spontaneous abortions are the most common complication of pregnancy. Clotrimazole
and miconazole are widely used vaginal-antimycotic agents used for the treatment of
vulvovaginal candidiasis. A previous study has suggested an increased risk of miscarriage
associated with these azoles, which may lead health professionals to refrain from
their use even if clinically indicated.
Objective
The aim of the current study was to assess the risk for spontaneous abortions following
first trimester exposure to vaginal antimycotics.
Study Design
A historical cohort study was conducted including all clinically apparent pregnancies
that began from January 2003 through December 2009 and admitted for birth or spontaneous
abortion at Soroka Medical Center, Clalit Health Services, Beer-Sheva, Israel. A computerized
database of medication dispensation was linked with 2 computerized databases containing
information on births and spontaneous abortions. Time-varying Cox regression models
were constructed adjusting for mother’s age, diabetes mellitus, hypothyroidism, obesity,
hypercoagulable or inflammatory conditions, recurrent miscarriages, intrauterine contraceptive
device, ethnicity, tobacco use, and the year of admission.
Results
A total of 65,457 pregnancies were included in the study: 58,949 (90.1%) ended with
birth and 6508 (9.9%) with a spontaneous abortion. Overall, 3246 (5%) pregnancies
were exposed to vaginal antimycotic medications until the 20th gestational week: 2712
(4.2%) were exposed to clotrimazole and 633 (1%) to miconazole. Exposure to vaginal
antimycotics was not associated with spontaneous abortions as a group (crude hazard
ratio, 1.11; 95% confidence interval, 0.96–1.29; adjusted hazard ratio, 1.11; 95%
confidence interval, 0.96–1.29) and specifically for clotrimazole (adjusted hazard
ratio, 1.05; 95% confidence interval, 0.89–1.25) and miconazole (adjusted hazard ratio,
1.34; 95% confidence interval, 0.99–1.80). Furthermore, no association was found between
categories of dosage of vaginal antimycotics and spontaneous abortions.
Conclusion
Exposure to vaginal antimycotics was not associated with spontaneous abortions.
Key words
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Article Info
Publication History
Published online: March 03, 2018
Accepted:
February 26,
2018
Received in revised form:
February 18,
2018
Received:
October 24,
2017
Footnotes
The authors report no conflict of interest.
Cite this article as: Daniel S, Rotem R, Koren G, et al. Vaginal antimycotics and the risk for spontaneous abortions. Am J Obstet Gynecol 2018;218:601.e1-7.
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© 2018 Elsevier Inc. All rights reserved.
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- ReplyAmerican Journal of Obstetrics & GynecologyVol. 219Issue 6
- PreviewWe thank Drs Xu and Du for their comment on our study. An adverse effect of a drug may develop in 2 ways: the first is a remote or a cumulative effect, in which an adverse phenomenon occurs relatively far from the exposure; the second is an acute effect, in which the adverse phenomenon occurs in the days after the exposure.
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- Vaginal antifungal during pregnancy and risk of spontaneous abortionsAmerican Journal of Obstetrics & GynecologyVol. 219Issue 6
- PreviewWe read with interest the article “Vaginal antimycotics and the risk for spontaneous abortions” by Daniel et al.1 The researchers used the medical center–based cohort of 65,457 pregnancies and compared those that were exposed to vaginal antifungal medications with up to 20 unexposed pregnancies. They found an insignificantly increased risk of spontaneous abortion associated with antimycotics exposure (crude hazard ratio, 1.11; 95% confidence interval, 0.96–1.29). Daniel et al concluded that “No increased risk for spontaneous abortions was detected following exposure to vaginal anti-mycotic drugs and the study reinforces the safety of use of these drugs (vaginal antimycotics) during the first trimester of pregnancy.” This is in accordance with the currently recommended advice that intravaginal formulations of topical azole antifungals are the first-line treatment for pregnant women.
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