Clinical trial NCT03181555: Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Official title: Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PREG1
Obesity
Keywords: Pregnant
Obese
Omic
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 25
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women
timeFrame: 27-28 weeks to 39 weeks of pregnancy
Secondary outcomes:
measure: Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women
timeFrame: 27-28 weeks to 39 weeks of pregnancy
Other outcomes:
Locations:
city: Irving
country: United States
facility: MacArthur OB/GYN
state: Texas
Study officials:
affiliation: Baylor University
name: Mary Ann Faucher, PhD
role: PRINCIPAL_INVESTIGATOR
References: