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

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

Study Overview

• Status: Completed
• Conditions: Obesity; PREG1
• Intervention / Treatment: Other: Exploratory

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75062
      • MacArthur OB/GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pregnant Obese African American Women; Exploratory	Other: Exploratory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women	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	27-28 weeks to 39 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women	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	27-28 weeks to 39 weeks of pregnancy

Collaborators and Investigators

• Sponsor: Baylor University
• Investigators: Principal Investigator: Mary Ann Faucher, PhD, Baylor University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Obese; Pregnant; Omic
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 916539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO