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The Reproductive Microbiome & Perinatal Health Outcomes

NCT02948192 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2020-01-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Discovery Foundation

    collaborator UNKNOWN

  • Baylor Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2019-11-01
Completion
2019-11-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02948192 on ClinicalTrials.gov