The Reproductive Microbiome & Perinatal Health Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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The Reproductive Microbiome & Perinatal Health Outcome

Conditions
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Human Microbiota, PreTerm Birth, Human Gastrointestinal Microbiota, Metabolomics

Intervention / Treatment
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* Other: Survey, Sample collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm Delivery<br>African american women who present for prenatal care who experience spontaneous preterm birth | Other: Survey, Sample collection<br>* Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.<br>|
| Term delivery<br>African american women who present for prenatal care who experience term birth | Other: Survey, Sample collection<br>* Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm Delivery, Preterm Birth, Vaginal Microbiome, Microbiome, Gut Microbiome, African American, Metabolomics, Pregnancy