Preterm BirthPREMEVA2NCT03618836
Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale
An observational study of Preterm Birth, run by University Hospital, Lille at 1 site in France.
Trial summary
Objective To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Microbiological and biological patterns on vaginal samples
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Dec 2014
- 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 years and older
- Women only
- Adult, Older adult
Study population: Cohort of pregnant patients in the first trimester
Who may be able to join
- case: spontaneous preterm births between 22 and 36 weeks in one of the 14 centers
- controls : the following delivery over ≥ 37 weeks in the same center
Who cannot join
- Multiple pregnancies, medical interruptions of pregnancy and deaths in utero
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)
Objective
To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries
Read the detailed description
Material and methods Case-control study nested in a cohort of pregnant patients in the first trimester. Inclusion criteria. : case is defined as spontaneous preterm births between 22 and 36 weeks in one of the 14 centers. The "control" patient will be considered as the following delivery over ≥ 37 weeks in the same center.
Multiple pregnancies, medical interruptions of pregnancy and deaths in utero will be excluded. Regarding the vaginal flora of cases and controls, the microorganisms will be researched and quantified by molecular methods.
Expected results
Patients and control patients will be compared for their demographic, obstetric, clinical and microbiological data. The parameters related to the risk of spontaneous prematurity at the p <0.20 threshold will then be analyzed by multi-level logistic regression.
Implications At a time when the link between bacterial vaginosis and prematurity is controversial, the detection - or not - of microorganisms linked to the risk of prematurity will be a key issue.
- Conditions
- Preterm Birth
- Being tested
- Microbiological and biological patterns on vaginal samples
- Keywords
- Bacterial vaginosis, Vaginal microbiota, Molecular methods, Next generation sequencing
- Medical subject headings
- Premature Birth, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological and biological patterns on vaginal samplesOther
To compare the microbiological and biological patterns between groups
| Study group | Role | What they receive |
|---|---|---|
| Cases. Preterm Births | Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among spontaneous preterm births between 22 and 36 weeks Receives: Other: Microbiological and biological patterns on vaginal samples | |
| Controls. Term Births | Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks Receives: Other: Microbiological and biological patterns on vaginal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Microbiota pattern
All microorganism potentially present in the vagina
Measured: 10 years
Secondary outcomes (1)
Vaginal biological pattern
Biochemical and immunological compounds present in the vagina
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study startNov 2011
- Primary completionJun 2013
- Study completionDec 2014
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 Hospital, LilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Damien Subtil, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618836
- Sponsor's protocol ID
- 2011_16
- Other IDs
- 2011-A01254-37, PHRC_N 2011N°19-22
- Acronym
- PREMEVA2
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 7 Aug 2018
- 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 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)
- ClinicalTrials.gov ID
- NCT03618836
- Acronym / sponsor ID
- PREMEVA2 / 2011_16
- Conditions
- Preterm Birth
- Keywords
- Bacterial vaginosis, Vaginal microbiota, Molecular methods, Next generation sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Aug 2018 (actual)
- 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.
Objective
To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries
Detailed description
Material and methods Case-control study nested in a cohort of pregnant patients in the first trimester. Inclusion criteria. : case is defined as spontaneous preterm births between 22 and 36 weeks in one of the 14 centers. The "control" patient will be considered as the following delivery over ≥ 37 weeks in the same center.
Multiple pregnancies, medical interruptions of pregnancy and deaths in utero will be excluded. Regarding the vaginal flora of cases and controls, the microorganisms will be researched and quantified by molecular methods.
Expected results
Patients and control patients will be compared for their demographic, obstetric, clinical and microbiological data. The parameters related to the risk of spontaneous prematurity at the p <0.20 threshold will then be analyzed by multi-level logistic regression.
Implications At a time when the link between bacterial vaginosis and prematurity is controversial, the detection - or not - of microorganisms linked to the risk of prematurity will be a key issue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases. Preterm Births | – | Other: Microbiological and biological patterns on vaginal samplesMicrobiological and biological patterns on vaginal samples in the first trimester of pregnancy among spontaneous preterm births between 22 and 36 weeks |
| Controls. Term Births | – | Other: Microbiological and biological patterns on vaginal samplesMicrobiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Cohort of pregnant patients in the first trimester
Key inclusion criteria (2 listed)
- case: spontaneous preterm births between 22 and 36 weeks in one of the 14 centers
- controls : the following delivery over ≥ 37 weeks in the same center
Key exclusion criteria (1 listed)
- Multiple pregnancies, medical interruptions of pregnancy and deaths in utero
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 |
|---|---|---|
| Microbiological and biological patterns on vaginal samplesTo compare the microbiological and biological patterns between groups | Other | Cases. Preterm Births, Controls. Term Births |
Primary outcome
Vaginal Microbiota pattern
Time frame: 10 years
All microorganism potentially present in the vagina
1 secondary outcome
Vaginal biological pattern
Time frame: 10 years
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 7 Aug 2018.
- 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.
Damien Subtil, MD,PhD principal investigator
University Hospital, Lille
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 Hospital, Lille at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 7 Aug 2018. 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 France. 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?
Vaginal Microbiota pattern (time frame: 10 years). 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 7 Aug 2018.