Human Gastrointestinal Microbiota, Human Microbiota, Metabolomics, PreTerm Birth
Conditions
Keywords
Preterm Delivery, Preterm Birth, Vaginal Microbiome, Microbiome, Gut Microbiome, African American, Metabolomics, Pregnancy
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.
Interventions
OTHERSurvey, 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.
Sponsors
Discovery Foundation
Baylor Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm Delivery | 36 weeks | Onset of preterm labor with subsequent spontaneous preterm birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome profile | 36 weeks | Evaluation of characteristics of the vaginal microbiome in cohorts |
| Metabolomic profile | 36 weeks | Evaluation of characteristics of the metabolomic products present in cohort |
| Medical comorbidities | 36 weeks | Evaluation of the comorbidities present in the cohort |
| Gut Microbiome profile | 36 weeks | Evaluation of the characteristics of the gastrointestinal microbiome in cohorts |
| Term delivery | 36 weeks | Delivery at term |
Outcome results
None listed