Preterm BirthM&MNCT02030106
Motherhood and Microbiome
An observational study of Preterm Birth, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Read more about this study
- Who is it for?
- Ages 13 to 50 years, women only
- Conditions the study is for
- Preterm Birth
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 1 Jun 2017
- 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 13 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O. Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be identified from clinical schedules and will be pre-screened in EPIC for eligibility. They may be approached during a clinical visit, or the research team may call them prior to or after a scheduled visit to introduce the study. Women can be enrolled anytime between the confirmation of pregnancy and 20 weeks/0 days gestation. For convenience, research visits can be conducted at the time of a scheduled clinical visit, or at a separate time.
Who may be able to join
- Pregnant women receiving care in University of Pennsylvania Health System
Who cannot join
- Non-singleton pregnancy (twins, triplets, etc.)
- Known major fetal anomaly
- Known HIV positive status
- History of organ transplant
- Chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.
Read the detailed description
Patients will be recruited around the time of their routine obstetrical visits. They will be asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit, vaginal swabs will be collected. The patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will perform chart abstraction after delivery.
- Conditions
- Preterm Birth
- Keywords
- Cervicovaginal microbiome, Microbiome, Preterm Birth, Cervical Remodeling, Preterm delivery, Microbiota
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prior Preterm Birth Patients | All obstetrical patients eligible for the study that have had a prior preterm birth. | |
| Term Birth Patients | All obstetrical patients eligible for the study that have not had a prior preterm birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervicovaginal Microbiota in Women With and Without Preterm Birth
Cervicovaginal Microbiota in Women With and Without Preterm Birth
Measured: Enrollment through delivery
Secondary outcomes (1)
Potential Modifiers of the Cervicovaginal Microbiome
Potential modifiers of the cervicovaginal microbiome: behavioral factors, stress, nutrition/obesity, vaginal infections, genetic or host immune differences, race and ethnicity, social behaviors, environmental influences
Measured: Enrollment through delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startOct 2013
- Primary completion3 Feb 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Michal A Elovitz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030106
- Sponsor's protocol ID
- 818914
- Other IDs
- R01NR014784-01
- Acronym
- M&M
- Status last verified
- Sep 2017
- First submitted
- 2 Jan 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
- ClinicalTrials.gov ID
- NCT02030106
- Acronym / sponsor ID
- M&M / 818914
- Conditions
- Preterm Birth
- Keywords
- Cervicovaginal microbiome, Microbiome, Preterm Birth, Cervical Remodeling, Preterm delivery, Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2013
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 8 Jan 2014 (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.
This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.
Detailed description
Patients will be recruited around the time of their routine obstetrical visits. They will be asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit, vaginal swabs will be collected. The patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will perform chart abstraction after delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior Preterm Birth Patients | – | –All obstetrical patients eligible for the study that have had a prior preterm birth. |
| Term Birth Patients | – | –All obstetrical patients eligible for the study that have not had a prior preterm birth. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O. Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be identified from clinical schedules and will be pre-screened in EPIC for eligibility. They may be approached during a clinical visit, or the research team may call them prior to or after a scheduled visit to introduce the study. Women can be enrolled anytime between the confirmation of pregnancy and 20 weeks/0 days gestation. For convenience, research visits can be conducted at the time of a scheduled clinical visit, or at a separate time.
Key inclusion criteria (1 listed)
- Pregnant women receiving care in University of Pennsylvania Health System
Key exclusion criteria (5 listed)
- Non-singleton pregnancy (twins, triplets, etc.)
- Known major fetal anomaly
- Known HIV positive status
- History of organ transplant
- Chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cervicovaginal Microbiota in Women With and Without Preterm Birth
Time frame: Enrollment through delivery
Cervicovaginal Microbiota in Women With and Without Preterm Birth
1 secondary outcome
Potential Modifiers of the Cervicovaginal Microbiome
Time frame: Enrollment through delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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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.
Michal A Elovitz, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University of Pennsylvania at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cervicovaginal Microbiota in Women With and Without Preterm Birth (time frame: Enrollment through delivery). 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 12 Sep 2017.