Bacterial Vaginosis and Spontaneous Abortion

细菌性阴道病和自然流产

• 批准号: 6331914
• 负责人: Deborah B Nelson
• 金额: $ 46.92万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-01 至 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6331914
• 关键词: African American; bacterial disease; caucasian American; cervical /vaginal smear; disease /disorder proneness /risk; drug detection; gestational age; human pregnant subject; interview; mass screening; patient oriented research; pregnancy; spontaneous abortion; statistics /biometry; telecommunications; urinalysis; vaginitis; women's health

DESCRIPTION: Bacterial vaginosis (BV) is extremely prevalent among low-income, urban pregnant women. The current standard of medical care does not involve screening pregnant women for BV unless clinical symptoms are reported; however, the majority of pregnant women with BV are asymptomatic. A number of studies have found associations between BV and late pregnancy outcomes; such as, preterm labor, premature rupture of membrane, chorioamnionitis, and low birth weight. The impact of BV on the risk for spontaneous abortion (SAB) is unclear. In the proposed prospective cohort study, all women will be screened for BV early in pregnancy regardless of symptoms. The specific aims of this study are to: 1) characterize the prevalence and predictors of BV in women early in pregnancy and 2) evaluate whether BV during pregnancy is an important, independent predictor of SAB. Women attending their first clinical prenatal care visit at the Hospital of the University of Pennsylvania Obstetric Clinic with a pregnancy of 12 weeks gestation or less as determined by last menstrual period will be recruited. We will screen all women for bacterial vaginosis and follow-up through 22 weeks gestation to identify women experiencing a spontaneous abortion. We will enroll 2200 women over a three year period arid compare SAB rates for the estimated 400 women found to test positive for BY (20 percent of patients) and the 1600 women found to test negative for By. Baseline data collection will be standardized and include a structured in-person interview, a vaginal smear used to detect By, and urine analysis to determine alcohol, cocaine and cotinine. Follow-up telephone interviews will be conducted at 22 weeks gestation to determine the status of pregnancy (SAB vs. non-SAB) and BV diagnosis and treatment. Pregnancy outcome status will also be ascertained through ongoing review of medical records, pathology logs and birth certificates. Initial analyses will be exploratory and descriptive, characterizing the prevalence and predictors of BV and the risk factors for SAB. The primary analysis will be logistic regression, with relative risks and 95 percent confidence intervals, to explore whether BV is an independent predictor of SAB. This study will provide a unique opportunity to evaluate the prevalence of BV among pregnant women and to determine the relationship between BV and incident SAB.

描述：细菌性阴道病（BV）在低收入人群中极其普遍， 城市孕妇。目前的医疗标准不包括 筛查孕妇的BV，除非报告临床症状;然而， 大多数BV孕妇无症状。多项研究 已经发现BV和晚期妊娠结局之间存在关联;例如， 早产、胎膜早破、绒毛膜炎和低出生率 重量. BV对自然流产（SAB）风险的影响尚不清楚。 在拟定的前瞻性队列研究中，将对所有女性进行BV筛查 怀孕初期，不管有什么症状。本研究的具体目的是 目的：1）描述女性早期BV的患病率和预测因素， 妊娠和2）评估妊娠期间BV是否是重要的， SAB的独立预测因素。妇女参加第一次临床产前检查 在宾夕法尼亚大学医院产科诊所进行护理访问 根据最后一次月经确定的妊娠期为12周或以下 期间将招聘。我们将对所有妇女进行细菌性阴道病筛查， 随访至妊娠22周，以确定经历妊娠的女性 自然流产我们将在三年内招募2200名妇女， 比较SAB率估计400名妇女发现测试阳性的BY（20 %的患者）和1600名女性被发现测试阴性。基线 数据收集将标准化，包括结构化的面对面 面谈时，用阴道涂片来检测By，并用尿液分析来确定 酒精可卡因和可替宁将进行后续电话访谈 在妊娠22周时确定妊娠状态（SAB与非SAB） 以及BV的诊断和治疗。妊娠结局状态也将 通过持续审查医疗记录、病理学日志和出生 证书.初步分析将是探索性和描述性的， 描述BV的患病率和预测因素以及 SAB。主要分析将是logistic回归，包括相对风险和 95%的置信区间，以探索BV是否是一个独立的 SAB的预测这项研究将提供一个独特的机会，以评估 孕妇中BV的患病率，并确定 BV和事故SAB。