The Reproductive Microbiome & Perinatal Health Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 主要终点
- Preterm Delivery
研究概览
简要总结
Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.
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
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to read and understand English, full decision making capabilities, African American (self-identified), Pregnant, At 20 weeks or less of gestation, Singleton pregnancy, 18-45 years of age
排除标准
- •Race other than African American, Advanced gestational age (>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.
结局指标
主要结局
Preterm Delivery
时间窗: 36 weeks
Onset of preterm labor with subsequent spontaneous preterm birth
次要结局
- Microbiome profile(36 weeks)
- Medical comorbidities(36 weeks)
- Metabolomic profile(36 weeks)
- Term delivery(36 weeks)
- Gut Microbiome profile(36 weeks)
