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NCT03618836 Clinical Trial

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

Preterm Birth Clinical Trial

— PREMEVA2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03618836
Other study ID # 2011_16
Secondary ID 2011-A01254-37PH
Status Completed
Phase
First received
Last updated
Start date November 2011
Est. completion date December 2014

Study information
Verified date August 2018
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2014
Est. primary completion date June 2013
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Microbiological and biological patterns on vaginal samples
To compare the microbiological and biological patterns between groups

Locations
Country Name City State
France Hôpital Jeanne de Flandres, CHRU Lille

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vaginal Microbiota pattern All microorganism potentially present in the vagina 10 years
Secondary Vaginal biological pattern Biochemical and immunological compounds present in the vagina 10 years
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