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

BMC Pregnancy and Childbirth

Research Article

George Kotsiou¹  Kristen Rickard²  Jonathan M Morris³  Christine L Roberts³ 

[1] Department of Microbiology and Infectious Diseases, Royal North Shore Hospital, NSW, Australia;Department of Obstetrics and Gynaecology, Royal North Shore Hospital, NSW, Australia;Kolling Institute of Medical Research, University of Sydney, NSW, Australia;Department of Obstetrics and Gynaecology, Royal North Shore Hospital, NSW, Australia;

关键词: Preterm Birth;    Candidiasis;    Bacterial Vaginosis;    Usual Care Group;    Clotrimazole;   

DOI  :  10.1186/1471-2393-11-18

 received in 2010-08-17, accepted in 2011-03-11,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundAlthough 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.MethodsWe 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.ResultsOf 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.ConclusionsA large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052224

【 授权许可】

CC BY   
© Roberts et al; licensee BioMed Central Ltd. 2011