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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2011

Open Access 01-12-2011 | Research article

Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

Authors: Christine L Roberts, Kristen Rickard, George Kotsiou, Jonathan M Morris

Published in: BMC Pregnancy and Childbirth | Issue 1/2011

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Abstract

Background

Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth.

Methods

We used a prospective, randomized, open-label, blinded-endpoint (PROBE) study design. Pregnant women presenting at <20 weeks gestation with singleton pregnancies self-collected a vaginal swab. Those who were asymptomatic and culture positive for Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg) or usual care (screening result is not revealed, no treatment). The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth <37 weeks gestation was also assessed.

Results

Of 779 women approached, 500 (64%) participated in candidiasis screening, and 98 (19.6%) had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03.

Conclusions

A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052​224
Literature
1.
Goldenberg RL, Culhane JF, Iams JD, Romero R: Epidemiology and causes of preterm birth. Lancet. 2008, 371 (9606): 75-84. 10.1016/S0140-6736(08)60074-4.CrossRefPubMed
2.
3.
Kiss H, Petricevic L, Husslein P: Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery. BMJ. 2004, 329 (7462): 371-10.1136/bmj.38169.519653.EB.CrossRefPubMedPubMedCentral
4.
Cotch MF, Hillier SL, Gibbs RS, Eschenbach DA: Epidemiology and outcomes associated with moderate to heavy Candida colonization during pregnancy. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1998, 178 (2): 374-380. 10.1016/S0002-9378(98)80028-8.CrossRefPubMed
5.
McGregor JA, French JI, Parker R, Draper D, Patterson E, Jones W, Thorsgard K, McFee J: Prevention of premature birth by screening and treatment for common genital tract infections: results of a prospective controlled evaluation. Am J Obstet Gynecol. 1995, 173 (1): 157-167. 10.1016/0002-9378(95)90184-1.CrossRefPubMed
6.
Czeizel AE, Rockenbauer M: A lower rate of preterm birth after clotrimazole therapy during pregnancy. Paediatr Perinat Epidemiol. 1999, 13 (1): 58-64. 10.1046/j.1365-3016.1999.00157.x.CrossRefPubMed
7.
Czeizel AE, Fladung B, Vargha P: Preterm birth reduction after clotrimazole treatment during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2004, 116 (2): 157-163. 10.1016/j.ejogrb.2004.02.011.CrossRefPubMed
8.
Banhidy F, Acs N, Puho EH, Czeizel AE: Rate of preterm births in pregnant women with common lower genital tract infection: a population-based study based on the clinical practice. J Matern Fetal Neonatal Med. 2009, 22 (5): 410-418. 10.1080/14767050902801645.CrossRefPubMed
9.
Morrison EA, Cushman LF: Prevention of preterm delivery. N Engl J Med. 2007, 357 (19): 1979-1980. 10.1056/NEJMc072557.CrossRefPubMed
10.
Sobel JD: Vulvovaginal candidosis. Lancet. 2007, 369 (9577): 1961-1971. 10.1016/S0140-6736(07)60917-9.CrossRefPubMed
11.
Young GL, Jewell D: Topical treatment for vaginal candidiasis (thrush) in pregnancy. Cochrane Database Syst Rev. 2001, CD000225-4
12.
Tabrizi SN, Pirotta MV, Rudland E, Garland SM: Detection of Candida species by PCR in self-collected vaginal swabs of women after taking antibiotics. Mycoses. 2006, 49 (6): 523-524. 10.1111/j.1439-0507.2006.01312.x.CrossRefPubMed
13.
Hansson L, Hedner T, Dahlof B: Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992, 1 (2): 113-119. 10.3109/08037059209077502.CrossRefPubMed
14.
Smith DH, Neutel JM, Lacourciere Y, Kempthorne-Rawson J: Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements. J Hypertens. 2003, 21 (7): 1291-1298. 10.1097/00004872-200307000-00016.CrossRefPubMed
15.
Chaim W, Mazor M, Wiznitzer A: The prevalence and clinical significance of intraamniotic infection with Candida species in women with preterm labor. Arch Gynecol Obstet. 1992, 251 (1): 9-15. 10.1007/BF02718273.CrossRefPubMed
16.
Figueroa R, Garry D, Elimian A, Patel K, Sehgal PB, Tejani N: Evaluation of amniotic fluid cytokines in preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2005, 18 (4): 241-247. 10.1080/13506120500223241.CrossRefPubMed
17.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010, 340: c869-10.1136/bmj.c869.CrossRefPubMedPubMedCentral
18.
Polk BF: Association of Chlamydia trachomatis and Mycoplasma hominis with intrauterine growth retardation and preterm delivery. The John Hopkins Study of Cervicitis and Adverse Pregnancy Outcome. Am J Epidemiol. 1989, 129 (6): 1247-1257.
19.
Czeizel AE, Toth M, Rockenbauer M: No teratogenic effect after clotrimazole therapy during pregnancy. Epidemiology. 1999, 10 (4): 437-440. 10.1097/00001648-199907000-00016.CrossRefPubMed
20.
Rosa FW, Baum C, Shaw M: Pregnancy outcomes after first-trimester vaginitis drug therapy. Obstet Gynecol. 1987, 69 (5): 751-755.PubMed
21.
Roberts CL, Morris JM, Rickard KR, Giles WB, Simpson JM, Kotsiou G, Bowen JR: Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077]. BMC Pregnancy and Childbirth. 2011, 11: 19-CrossRefPubMedPubMedCentral
Metadata
Title
Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial
Authors
Christine L Roberts
Kristen Rickard
George Kotsiou
Jonathan M Morris
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2011
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-11-18

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