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Completed

NCT Number: NCT03618836

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

Objective

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

Completed

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Key information

Conditions

Preterm Birth Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Jeanne de Flandres, CHRU

Lille, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiological and biological patterns on vaginal samples

Other

To compare the microbiological and biological patterns between groups

Primary outcomes

  1. Vaginal Microbiota pattern

    Time frame: 10 years

    All microorganism potentially present in the vagina

Secondary outcomes

  1. Vaginal biological pattern

    Time frame: 10 years

    Biochemical and immunological compounds present in the vagina

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: PREMEVA2

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 7, 2018
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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