Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077]

BMC Pregnancy and Childbirth

Study Protocol

Warwick B Giles¹  Kristen R Rickard¹  Christine L Roberts²  George Kotsiou³  Jennifer R Bowen⁴  Jonathan M Morris⁵  Judy M Simpson⁶ 

[1] Clinical and Population Perinatal Health Research, Kolling Institute of Medical Research, University of Sydney, NSW, Australia;Department of Obstetrics and Gynaecology, Royal North Shore Hospital, NSW, Australia;Clinical and Population Perinatal Health Research, Kolling Institute of Medical Research, University of Sydney, NSW, Australia;Department of Obstetrics and Gynaecology, University of Sydney, NSW, Australia;Department of Microbiology and Infectious Diseases, Royal North Shore Hospital, NSW, Australia;Department of Neonatology, Royal North Shore Hospital, NSW, Australia;Department of Obstetrics and Gynaecology, University of Sydney, NSW, Australia;Department of Obstetrics and Gynaecology, Royal North Shore Hospital, NSW, Australia;School of Public Health, University of Sydney, NSW, Australia;

关键词: Preterm Birth;    Candidiasis;    Bacterial Vaginosis;    Clotrimazole;    Data Monitoring Committee;   

DOI  :  10.1186/1471-2393-11-19

 received in 2010-08-23, accepted in 2011-03-11,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundPrevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases.Methods/DesignUsing a prospective, randomised, open-label, blinded-endpoint (PROBE) study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care <20 weeks gestation with singleton pregnancies are eligible for inclusion. The intervention is a 6-day course of clotrimazole vaginal pessaries (100 mg) and the primary outcome is spontaneous preterm birth <37 weeks gestation.The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone) to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care). Outcomes will be obtained from population databases.A sample size of 3,208 women with Candida colonisation (1,604 per arm) is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8). Analyses will be by intention to treat.DiscussionFor our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design.This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in pregnancy significantly reduces the rate of spontaneous preterm birth. If it can be demonstrated that treating asymptomatic candidiasis reduces preterm births this will change current practice and would directly impact the management of every pregnant woman.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000607077

【 授权许可】

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