Recovery of Vaginal Flora after Douching Cessation

描述(由申请者提供)：阴道冲洗是一种常见的行为，巴尔的摩之前的研究发现，巴尔的摩性病诊所70%的女性报告目前正在冲洗。冲洗与许多不良后果有关，包括细菌性阴道病(BV)、宫颈感染、盆腔炎(PID)和增加异位妊娠的风险。BV尤其与早产、低出生体重和艾滋病毒的风险增加有关。大多数评估冲洗对BV风险的影响的研究都局限于对女性卫生行为的评估，而且主要是横断面的，限制了直接的因果推断。关于冲洗在短期或长期内如何影响阴道菌群，以及女性为什么冲洗，几乎没有数据可用。到目前为止，还没有研究评估停止冲洗后的阴道菌群。我们建议进行阴道冲洗的交叉干预试验，以评估停止冲洗后阴道菌群的变化。我们将招募150名目前从张贴的传单、湾景医疗中心妇科诊所和巴尔的摩市卫生局性病诊所进行冲洗的女性。我们将在一个月的冲洗期间，每周两次从自己收集的样本中测量阴道菌群(根据纽金特的标准)。然后，受试者将被要求停止冲洗，我们将在两个月内每周测量两次阴道菌群。在研究结束时恢复正常冲洗模式的女性也将接受第二次交叉暴露样本的评估。参与者将在整个研究过程中保持每日的性和卫生日记。综合评估公式将被用来评估以下方面：1)停止阴道冲洗对BV风险的影响；2)不冲洗但随后又恢复以前冲洗习惯的女性患BV的风险。还将评估常见的阴道冲洗做法、动机和技术。这项研究的数据将开始描述BV的自然历史，并帮助设计阴道冲洗的行为干预措施。

DESCRIPTION (provided by applicant): Vaginal douching is a commonly practiced behavior and previous work in Baltimore found that 70 percent of women in the Baltimore STD clinics report current douching. Douching is associated with a number of adverse outcomes, including bacterial vaginosis (BV), cervical infection, pelvic inflammatory disease (PID), and increased risk for ectopic pregnancy. BV, in particular, is associated with an increased risk of pre-term delivery, low birth weight and HIV. Most studies evaluating the effect of douching on risk for BV have been limited in their evaluation of feminine hygiene behavior and have been largely cross-sectional, limiting direct causal inference. Little data are available on how douching affects the vaginal flora on either a short or long-term basis or why women douche. No studies to date have evaluated vaginal flora after discontinuation of douching. We propose a cross-over intervention trial of vaginal douching to evaluate the change in vaginal flora after cessation of douching. We will recruit 150 women who currently douche from posted flyers, the Bayview Medical Center Gynecology clinic and Baltimore City Health Department STD clinics. We will measure the vaginal flora from self-collected samples (with Nugent's criteria) twice per week during a one month douching period. Subjects will then be asked to stop douching, and we will measure vaginal flora twice weekly for two months. Women who return to their normal douching patterns at the conclusion of the study will also be evaluated for a second cross-over exposure sample. Participants will maintain daily sexual and hygiene diaries throughout the study. Generalized estimating equations will be used to assess the following: 1) the effect of vaginal douching cessation on the risk of BV; 2) the risk for BV among women who abstain from douching but then revert to their previous douching habits. Common vaginal douching practices, motivations and techniques will also be evaluated. Data from this research will begin to describe the natural history of BV and aid in the design of behavioral interventions for vaginal douching.