The Reproductive Microbiome & Perinatal Health Outcomes
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| ClinicalTrials.gov Identifier: NCT02948192 |
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Recruitment Status :
Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : January 19, 2018
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Sponsor:
Baylor Research Institute
Collaborator:
Discovery Foundation
Information provided by (Responsible Party):
Baylor Research Institute
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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 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Preterm Delivery
African american women who present for prenatal care who experience spontaneous preterm birth
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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. |
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Term delivery
African american women who present for prenatal care who experience term birth
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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. |
Primary Outcome Measures :
- Preterm Delivery [ Time Frame: 36 weeks ]Onset of preterm labor with subsequent spontaneous preterm birth
Secondary Outcome Measures :
- Microbiome profile [ Time Frame: 36 weeks ]Evaluation of characteristics of the vaginal microbiome in cohorts
- Metabolomic profile [ Time Frame: 36 weeks ]Evaluation of characteristics of the metabolomic products present in cohort
- Medical comorbidities [ Time Frame: 36 weeks ]Evaluation of the comorbidities present in the cohort
- Gut Microbiome profile [ Time Frame: 36 weeks ]Evaluation of the characteristics of the gastrointestinal microbiome in cohorts
- Term delivery [ Time Frame: 36 weeks ]Delivery at term
Biospecimen Retention: Samples Without DNA
Sample collection for bacterial microbiome identification and metabolic products
Information from the National Library of Medicine
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| 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.
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
| Responsible Party: | 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: | January 19, 2018 |
| Last Verified: | January 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Baylor Research Institute:
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Preterm Delivery Preterm Birth Vaginal Microbiome Microbiome |
Gut Microbiome African American Metabolomics Pregnancy |
Additional relevant MeSH terms:
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |