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

NCT ID: NCT03181555

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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PREG1 Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

No masking. A convenience sample of pregnant AA women will be recruited based on race/ethnicity and body mass index.

Study Groups

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Pregnant Obese African American Women

Exploratory

Group Type OTHER

Exploratory

Intervention Type OTHER

Interventions

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Exploratory

Intervention Type OTHER

Eligibility Criteria

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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).


3\. History of chronic disease on medications
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor University

OTHER

Sponsor Role lead

Responsible Party

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Mary Ann Faucher

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Ann Faucher, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

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MacArthur OB/GYN

Irving, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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916539

Identifier Type: -

Identifier Source: org_study_id