Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women

Not Applicable

Completed

• Conditions: PREG1; Obesity
• Interventions: Other: Exploratory

• Registration Number: NCT03181555
• Lead Sponsor: Baylor University

Brief Summary

1. Determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of African American women differ from their pregnant non-obese counterparts

2. Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant African-American women.

3. Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (PTB) and onset of labor.

4. Determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with PTB

Detailed Description

This is an exploratory pilot study to determine the omic footprint in pregnant AA women and then compare difference between obese and non-obese pregnant AA women and comparisons by class of obesity. Variations in the omic findings (vaginal and gut microbiome and urinary metabolites) will be assessed by dietary findings and by variations in gestational weight gain.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Age 20 or older English Speaking Access to internet- The dietary assessment for this study is The Automated Self-Administered 24-hour Recall (ASA24-2014), a web-based instrument developed by researchers at the National Cancer Institute (NCI).

Exclusion Criteria

• 1. History of preterm birth and taking progesterone. Progesterone may influence the microbiota and metabolites so therefore these women will not be eligible for the study. However, if the women fit other inclusion criteria and have a history of preterm birth but are not on progesterone they will be eligible for enrollment 2. History of antibiotic use in the last month (includes pre-biotics and probiotics). These medications will change the baseline microbiota.

3. History of chronic disease on medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant Obese African American Women	Exploratory	Exploratory

Primary Outcome Measures

Name	Time	Method
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women	27-28 weeks to 39 weeks of pregnancy	The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared with non-obese pregnant AA women. This comparison will be investigated by diet and gestational weight gain

Secondary Outcome Measures

Name	Time	Method
Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women	27-28 weeks to 39 weeks of pregnancy	The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared by class of obesity. This comparison will be investigated by diet and gestational weight gain

Trial Locations

Locations (1)

MacArthur OB/GYN; 🇺🇸 Irving, Texas, United States