The Reproductive Microbiome & Perinatal Health Outcomes

Terminated

• Conditions: PreTerm Birth; Human Gastrointestinal Microbiota; Human Microbiota; Metabolomics
• Interventions: Other: Survey, Sample collection

• Registration Number: NCT02948192
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Study Start: 2016-11-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm Delivery	Survey, Sample collection	African american women who present for prenatal care who experience spontaneous preterm birth
Term delivery	Survey, Sample collection	African american women who present for prenatal care who experience term birth

Primary Outcome Measures

Name	Time	Method
Preterm Delivery	36 weeks	Onset of preterm labor with subsequent spontaneous preterm birth

Secondary Outcome Measures

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