The Reproductive Microbiome & Perinatal Health Outcomes

Baylor Scott and White Health (BSWH)

Status: Terminated

Conditions: Metabolomics; PreTerm Birth; Human Gastrointestinal Microbiota; Human Microbiota

Treatments: Other: Survey, Sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT02948192

016-194

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

55 participants in 2 patient groups

Preterm Delivery

Description:

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

Treatment:

Other: Survey, Sample collection

Term delivery

Description:

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

Treatment:

Other: Survey, Sample collection