The Reproductive Microbiome & Perinatal Health Outcomes

PreTerm Birth Clinical Trial

Official title:

The Reproductive Microbiome & Perinatal Health Outcome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02948192
• Other study ID #: 016-194
• Status: Terminated
• Start date: November 1, 2016
• Est. completion date: November 1, 2019

Study information

• Verified date: January 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Gastrointestinal Microbiota
• Human Microbiota
• Metabolomics
• Premature Birth
• PreTerm Birth

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Discovery Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm Delivery	Onset of preterm labor with subsequent spontaneous preterm birth	36 weeks
Secondary	Microbiome profile	Evaluation of characteristics of the vaginal microbiome in cohorts	36 weeks
Secondary	Metabolomic profile	Evaluation of characteristics of the metabolomic products present in cohort	36 weeks
Secondary	Medical comorbidities	Evaluation of the comorbidities present in the cohort	36 weeks
Secondary	Gut Microbiome profile	Evaluation of the characteristics of the gastrointestinal microbiome in cohorts	36 weeks
Secondary	Term delivery	Delivery at term	36 weeks