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

Obesity Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03181555
Study type Interventional
Source Baylor University
Contact
Status Completed
Phase N/A
Start date August 2016
Completion date August 2017
View Details
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