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

Completed

• Conditions: Preterm Birth
• Interventions: Other: Microbiological and biological patterns on vaginal samples

• Registration Number: NCT03618836
• Lead Sponsor: University Hospital, Lille

Brief Summary

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2013-06
• Study Completion: 2014-12
• Status Verified: 2018-08
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-07
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls. Term Births	Microbiological and biological patterns on vaginal samples	Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks
Cases. Preterm Births	Microbiological and biological patterns on vaginal samples	Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among spontaneous preterm births between 22 and 36 weeks

Primary Outcome Measures

Name	Time	Method
Vaginal Microbiota pattern	10 years	All microorganism potentially present in the vagina

Secondary Outcome Measures

Name	Time	Method
Vaginal biological pattern	10 years	Biochemical and immunological compounds present in the vagina

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres, CHRU; 🇫🇷 Lille, France