Bacterial Vaginosis and Spontaneous Abortion

细菌性阴道病和自然流产

• 批准号: 6637934
• 负责人: Deborah B Nelson
• 金额: $ 61.15万
• 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/6637934
• 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）在低收入中极为普遍 城市孕妇。目前的医疗标准不涉及 除非有临床症状，否则筛查孕妇的BV；然而， 大多数BV孕妇无症状。许多研究 已经发现了BV与妊娠晚期之间的关联；例如， 早产，膜炎，绒毛膜炎和低出生的过早破裂 重量。 BV对自发流产（SAB）风险的影响尚不清楚。 在拟议的前瞻性队列研究中，所有妇女将被筛选为BV 怀孕初期，无论症状如何。这项研究的具体目的是 至：1）在早期的女性中表征BV的患病率和预测因子 怀孕和2）评估怀孕期间的BV是否重要， SAB的独立预测指标。妇女参加第一个临床产前 宾夕法尼亚大学产科诊所的医院护理参观 通过最后一个月经确定的妊娠12周或更少的妊娠期 期间将被招募。我们将筛选所有女性的细菌性阴道病和 随访至22周妊娠，以确定经历的女性 自发流产。我们将在三年的干旱期间注册2200名妇女 比较估计的400名妇女的SAB率，该妇女对阳性测试呈阳性（20 患者的百分比）和1600名妇女对by进行了阴性测试。基线 数据收集将是标准化的，并包括一个结构化的人 访谈，一种用于检测的阴道涂片，尿液分析以确定 酒精，可卡因和可甲胺。将进行后续电话采访 妊娠22周以确定妊娠状态（SAB与非SAB） 和BV诊断​​和治疗。怀孕结局状况也将是 通过对病历，病理日志和出生的持续审查确定 证书。初始分析将具有探索性和描述性， 表征BV的患病率和预测因素和风险因素 sab。主要分析将是逻辑回归，具有相对风险， 95％的置信区间，探索BV是否是独立的 SAB的预测指标。这项研究将提供一个独特的机会来评估 BV在孕妇中的患病率，并确定 BV和事件SAB。