Preterm Birth Clinical Trial
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
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.
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