Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Completed · Not applicable
Conditions studied: PREG1, Obesity
In brief
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
Key facts
- Study ID
- NCT03181555
- Run by
- Baylor University
- People needed
- 25
- Starts
- 2016-08-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2017-09-21
Who can join
Age: 20 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
- History of chronic disease on medications
Where it is running
- MacArthur OB/GYN — Irving, Texas, United States
Full record on ClinicalTrials.gov
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