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

NCT03181555 | Completed

• 1 other identifier: 916539
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PREG1; Obesity

Keywords

Pregnant; Obese; Omic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Pregnant Obese African American Women

OTHER

Exploratory

Other: Exploratory

Interventions

Exploratory OTHER

Pregnant Obese African American Women

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• \. History of chronic disease on medications

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

MacArthur OB/GYN

Irving, Texas, 75062, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Ann Faucher, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking. A convenience sample of pregnant AA women will be recruited based on race/ethnicity and body mass index.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: June 9, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)