Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lille, France
- Hôpital Jeanne de Flandres, CHRU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Multiple pregnancies, medical interruptions of pregnancy and deaths in utero
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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To compare the microbiological and biological patterns between groups
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Controls. Term Births
Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks
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To compare the microbiological and biological patterns between groups
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaginal Microbiota pattern
Time Frame: 10 years
|
All microorganism potentially present in the vagina
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10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaginal biological pattern
Time Frame: 10 years
|
Biochemical and immunological compounds present in the vagina
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10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011_16
- 2011-A01254-37 (Other Identifier: ID-RCB number, ANSM)
- PHRC_N 2011N°19-22 (Other Identifier: PHRC number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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