Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Cervicovaginal Microbiota in Women With and Without Preterm Birth
研究概览
简要总结
This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.
详细描述
Patients will be recruited around the time of their routine obstetrical visits. They will be asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit, vaginal swabs will be collected. The patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will perform chart abstraction after delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women receiving care in University of Pennsylvania Health System
排除标准
- •Non-singleton pregnancy (twins, triplets, etc.)
- •Known major fetal anomaly
- •Known HIV positive status
- •History of organ transplant
- •Chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)
结局指标
主要结局
Cervicovaginal Microbiota in Women With and Without Preterm Birth
时间窗: Enrollment through delivery
Cervicovaginal Microbiota in Women With and Without Preterm Birth
次要结局
- Potential Modifiers of the Cervicovaginal Microbiome(Enrollment through delivery)