We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Reproductive Microbiome & Perinatal Health Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02948192
Recruitment Status : Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.

Condition or disease Intervention/treatment
Human Microbiota PreTerm Birth Human Gastrointestinal Microbiota Metabolomics Other: Survey, Sample collection

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Reproductive Microbiome & Perinatal Health Outcome
Study Start Date : November 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : April 2020
Groups and Cohorts

Group/Cohort Intervention/treatment
Preterm Delivery
African american women who present for prenatal care who experience spontaneous preterm birth
Other: Survey, Sample collection
Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.
Term delivery
African american women who present for prenatal care who experience term birth
Other: Survey, Sample collection
Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.


Outcome Measures

Primary Outcome Measures :
  1. Preterm Delivery [ Time Frame: 36 weeks ]
    Onset of preterm labor with subsequent spontaneous preterm birth


Secondary Outcome Measures :
  1. Microbiome profile [ Time Frame: 36 weeks ]
    Evaluation of characteristics of the vaginal microbiome in cohorts

  2. Metabolomic profile [ Time Frame: 36 weeks ]
    Evaluation of characteristics of the metabolomic products present in cohort

  3. Medical comorbidities [ Time Frame: 36 weeks ]
    Evaluation of the comorbidities present in the cohort

  4. Gut Microbiome profile [ Time Frame: 36 weeks ]
    Evaluation of the characteristics of the gastrointestinal microbiome in cohorts

  5. Term delivery [ Time Frame: 36 weeks ]
    Delivery at term


Biospecimen Retention:   Samples Without DNA
Sample collection for bacterial microbiome identification and metabolic products

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
African american women between 18 and 45 years of age who are pregnant with a singleton and present for prenatal care at 20 weeks of gestation or less.
Criteria

Inclusion Criteria:

  • Able to read and understand English, full decision making capabilities, African American (self-identified), Pregnant, At 20 weeks or less of gestation, Singleton pregnancy, 18-45 years of age

Exclusion Criteria:

  • Race other than African American, Advanced gestational age (>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.
Contacts and Locations

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): NCT02948192


Contacts
Contact: Adrianne C Browning, MD 214-820-6756 adrianne.browning@bswhealth.org
Contact: Marie Hastings-Tolsma, PhD 720-539-6317 marie_hastings-tosma@baylor.edu

Sponsors and Collaborators
Baylor Research Institute
Discovery Foundation
More Information

Responsible Party: Adrianne Browning, Assistant Professor, Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02948192     History of Changes
Other Study ID Numbers: 016-194
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Adrianne Browning, Baylor Research Institute:
Preterm Delivery
Preterm Birth
Vaginal Microbiome
Microbiome
Gut Microbiome
African American
Metabolomics
Pregnancy

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications