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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03618836
Acronym
PREMEVA2
Enrollment
1000
Registered
2018-08-07
Start date
2011-11-30
Completion date
2014-12-31
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Bacterial vaginosis, Vaginal microbiota, Molecular methods, Next generation sequencing

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.

Interventions

OTHERMicrobiological and biological patterns on vaginal samples

To compare the microbiological and biological patterns between groups

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Vaginal Microbiota pattern10 yearsAll microorganism potentially present in the vagina

Secondary

MeasureTime frameDescription
Vaginal biological pattern10 yearsBiochemical and immunological compounds present in the vagina

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026