The Reproductive Microbiome & Perinatal Health Outcomes

The Reproductive Microbiome & Perinatal Health Outcome

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.

Study Overview

• Status: Terminated
• Conditions: PreTerm Birth; Metabolomics; Human Microbiota; Human Gastrointestinal Microbiota
• Intervention / Treatment: Other: Survey, Sample collection

• Study Type: Observational
• Enrollment (Actual): 55

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm Delivery; African american women who present for prenatal care who experience spontaneous preterm birth	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.
Term delivery; African american women who present for prenatal care who experience term birth	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm Delivery	Onset of preterm labor with subsequent spontaneous preterm birth	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome profile	Evaluation of characteristics of the vaginal microbiome in cohorts	36 weeks
Metabolomic profile	Evaluation of characteristics of the metabolomic products present in cohort	36 weeks
Medical comorbidities	Evaluation of the comorbidities present in the cohort	36 weeks
Gut Microbiome profile	Evaluation of the characteristics of the gastrointestinal microbiome in cohorts	36 weeks
Term delivery	Delivery at term	36 weeks

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Discovery Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Microbiome; Pregnancy; Metabolomics; African American; Gut Microbiome; Preterm Birth; Preterm Delivery; Vaginal Microbiome
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 016-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO