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

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ClinicalTrials.gov Identifier: NCT03181555
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Mary Ann Faucher, Baylor University

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

Condition or disease Intervention/treatment Phase
PREG1 Obesity Other: Exploratory Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: No masking. A convenience sample of pregnant AA women will be recruited based on race/ethnicity and body mass index.
Primary Purpose: Basic Science
Official Title: Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pregnant Obese African American Women
Exploratory
Other: Exploratory



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


Secondary Outcome Measures :
  1. Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women [ Time Frame: 27-28 weeks to 39 weeks of pregnancy ]
    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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181555


Locations
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United States, Texas
MacArthur OB/GYN
Irving, Texas, United States, 75062
Sponsors and Collaborators
Baylor University
Investigators
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Principal Investigator: Mary Ann Faucher, PhD Baylor University

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Responsible Party: Mary Ann Faucher, Associate Professor, Baylor University
ClinicalTrials.gov Identifier: NCT03181555     History of Changes
Other Study ID Numbers: 916539
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mary Ann Faucher, Baylor University:
Pregnant
Obese
Omic
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications