Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale

Study Overview
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Brief Summary
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Objective To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries

Detailed Description
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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.

Official Title
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Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)

Conditions
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Preterm Birth

Intervention / Treatment
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* Other: Microbiological and biological patterns on vaginal samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases. Preterm Births<br>Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among spontaneous preterm births between 22 and 36 weeks | Other: Microbiological and biological patterns on vaginal samples<br>* To compare the microbiological and biological patterns between groups<br>|
| Controls. Term Births<br>Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks | Other: Microbiological and biological patterns on vaginal samples<br>* To compare the microbiological and biological patterns between groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Microbiota pattern | All microorganism potentially present in the vagina | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal biological pattern | Biochemical and immunological compounds present in the vagina | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal microbiota, Bacterial vaginosis, Molecular methods, Next generation sequencing