The Reproductive Microbiome & Perinatal Health Outcomes

NCT02948192 | Terminated

• 1 other identifier: 016-194
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Preterm Delivery; Preterm Birth; Vaginal Microbiome; Microbiome; Gut Microbiome; African American; Metabolomics; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Preterm Delivery

  Onset of preterm labor with subsequent spontaneous preterm birth

  36 weeks

Secondary Outcomes (5)

• Microbiome profile

  36 weeks

• Metabolomic profile

  36 weeks

• Medical comorbidities

  36 weeks

• Gut Microbiome profile

  36 weeks

• Term delivery

  36 weeks

Study Arms (2)

Preterm Delivery

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

Other: Survey, Sample collection

Term delivery

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

Other: Survey, Sample collection

Interventions

Survey, Sample collection OTHER

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

Preterm Delivery; Term delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

African american women between 18 and 45 years of age who are pregnant with a singleton and present for prenatal care at 20 weeks of gestation or less.

You may qualify if:

• 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

You may not qualify if:

• Race other than African American, Advanced gestational age (\>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.

Sponsors & Collaborators

• Baylor Research Institute: lead
• Discovery Foundation: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sample collection for bacterial microbiome identification and metabolic products

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires; Specimen Handling

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 28, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share