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

University Hospital, Lille

Status: Completed

Conditions: Preterm Birth

Treatments: Other: Microbiological and biological patterns on vaginal samples

Study type: Observational

Funder types: Other

Identifiers

NCT03618836

PHRC_N 2011N°19-22 (Other Identifier)

2011-A01254-37 (Other Identifier)

2011_16

Details and patient eligibility

About

Objective

To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries

Full 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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Cases. Preterm Births

Description:

Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among spontaneous preterm births between 22 and 36 weeks

Treatment:

Other: Microbiological and biological patterns on vaginal samples

Controls. Term Births

Description:

Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks

Treatment:

Other: Microbiological and biological patterns on vaginal samples