Kolling Institute of Medical Research, University of Sydney, NSW Australia.
BMC Pregnancy Childbirth. 2011 Mar 11;11:18. doi: 10.1186/1471-2393-11-18.
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.
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.
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.
A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052224.
虽然上行感染与早产之间的联系是毋庸置疑的，但寻找有效治疗方法的研究却令人失望。然而，越来越多的证据表明，在怀孕期间消除念珠菌可能会降低早产的风险。我们进行了一项试点研究，以评估进行大型随机对照试验的可行性，以确定在妊娠早期无症状性念珠菌病的治疗是否会降低早产的发生率。
我们使用了前瞻性、随机、开放标签、盲终点（PROBE）研究设计。在<20 周妊娠时出现单胎妊娠的孕妇自行采集阴道拭子。那些无症状且培养出念珠菌阳性的孕妇被随机分为 6 天克霉唑阴道栓剂（100mg）或常规护理（不透露筛查结果，不进行治疗）。主要结局是无症状性阴道念珠菌病的发生率、参与率和随访率。也评估了拟议的主要试验结局，即自发性早产<37 周妊娠的发生率。
在 779 名被接触的女性中，有 500 名（64%）参与了念珠菌病筛查，98 名（19.6%）有无症状性阴道念珠菌病并被随机分为克霉唑或常规护理组。参与研究、实验室检测和药物配药对女性没有造成不便，随访率为 99%。在接受克霉唑治疗的无症状性念珠菌病女性中，自发性早产的发生率有降低的趋势 RR=0.33，95%CI 0.04-3.03。
在无症状性念珠菌病孕妇中使用克霉唑预防早产的大型、充分有力、随机试验既可行又有必要。
澳大利亚和新西兰临床试验注册中心（ANZCTR）：ACTRN12609001052224。
