NCT02948192

The Reproductive Microbiome & Perinatal Health Outcomes

The Reproductive Microbiome & Perinatal Health Outcome

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Human Microbiota
• PreTerm Birth
• Human Gastrointestinal Microbiota
• Metabolomics

Interventions

Type	Name	Description
OTHER	Survey, Sample collection	Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-10-28
• Last updated: 2020-01-18