Human MicrobiotaNCT02948192
The Reproductive Microbiome & Perinatal Health Outcomes
An observational study of Human Microbiota and PreTerm Birth, run by Baylor Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Microbiota, PreTerm Birth, Human Gastrointestinal Microbiota
- What is being tested?
- Survey, Sample collection
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Race other than African American, Advanced gestational age (>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.
About this study
Official title: The Reproductive Microbiome & Perinatal Health Outcome
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.
- Being tested
- Survey, Sample collection
- Keywords
- Preterm Delivery, Preterm Birth, Vaginal Microbiome, Microbiome, Gut Microbiome, African American, Metabolomics, Pregnancy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey, Sample collectionOther
Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Delivery | African american women who present for prenatal care who experience spontaneous preterm birth Receives: Other: Survey, Sample collection | |
| Term delivery | African american women who present for prenatal care who experience term birth Receives: Other: Survey, Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Delivery
Onset of preterm labor with subsequent spontaneous preterm birth
Measured: 36 weeks
Secondary outcomes (5)
Microbiome profile
Evaluation of characteristics of the vaginal microbiome in cohorts
Measured: 36 weeks
Metabolomic profile
Evaluation of characteristics of the metabolomic products present in cohort
Measured: 36 weeks
Medical comorbidities
Evaluation of the comorbidities present in the cohort
Measured: 36 weeks
Gut Microbiome profile
Evaluation of the characteristics of the gastrointestinal microbiome in cohorts
Measured: 36 weeks
Term delivery
Delivery at term
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Inability to obtain final specimen routinely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiotaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Discovery Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948192
- Sponsor's protocol ID
- 016-194
- Status last verified
- Jan 2020
- First submitted
- 26 Oct 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reproductive Microbiome & Perinatal Health Outcome
- ClinicalTrials.gov ID
- NCT02948192
- Acronym / sponsor ID
- 016-194
- Keywords
- Preterm Delivery, Preterm Birth, Vaginal Microbiome, Microbiome, Gut Microbiome, African American, Metabolomics, Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to obtain final specimen routinely
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Discovery Foundation
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Delivery | – | Other: Survey, Sample collectionAfrican american women who present for prenatal care who experience spontaneous preterm birth |
| Term delivery | – | Other: Survey, Sample collectionAfrican american women who present for prenatal care who experience term birth |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Race other than African American, Advanced gestational age (>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey, Sample collectionSurvey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points. | Other | Preterm Delivery, Term delivery |
Primary outcome
Preterm Delivery
Time frame: 36 weeks
Onset of preterm labor with subsequent spontaneous preterm birth
5 secondary outcomes
Microbiome profile
Time frame: 36 weeks
Metabolomic profile
Time frame: 36 weeks
Medical comorbidities
Time frame: 36 weeks
Gut Microbiome profile
Time frame: 36 weeks
Term delivery
Time frame: 36 weeks
Results and safety
The study was stopped early (reason given: Inability to obtain final specimen routinely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Microbiota and PreTerm Birth, run by Baylor Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to obtain final specimen routinely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Delivery (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.