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

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ClinicalTrials.gov Identifier: NCT03618836
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:

Objective

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


Condition or disease Intervention/treatment
Preterm Birth Other: Microbiological and biological patterns on vaginal samples

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 Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2014
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cases. Preterm Births
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
To compare the microbiological and biological patterns between groups
Controls. Term Births
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
To compare the microbiological and biological patterns between groups


Outcome Measures
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Primary Outcome Measures :
  1. Vaginal Microbiota pattern [ Time Frame: 10 years ]
    All microorganism potentially present in the vagina


Secondary Outcome Measures :
  1. Vaginal biological pattern [ Time Frame: 10 years ]
    Biochemical and immunological compounds present in the vagina


Biospecimen Retention:   Samples With DNA
Vaginal samples with DNA of microorganisms

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Cohort of pregnant patients in the first trimester
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618836


Locations
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France
Hôpital Jeanne de Flandres, CHRU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Damien Subtil, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03618836    
Other Study ID Numbers: 2011_16
2011-A01254-37 ( Other Identifier: ID-RCB number, ANSM )
PHRC_N 2011N°19-22 ( Other Identifier: PHRC number )
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
Bacterial vaginosis
Vaginal microbiota
Molecular methods
Next generation sequencing
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications