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临床试验/NCT02948192
NCT02948192终止不适用

The Reproductive Microbiome & Perinatal Health Outcome

Baylor Research Institute0 个研究点目标入组 55 人开始时间: 2016年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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