The Reproductive Microbiome & Perinatal Health Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Microbiota PreTerm Birth Human Gastrointestinal Microbiota Metabolomics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Delivery

African american women who present for prenatal care who experience spontaneous preterm birth

Survey, Sample collection

Intervention Type OTHER

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

Term delivery

African american women who present for prenatal care who experience term birth

Survey, Sample collection

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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