Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC).

There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity.

The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies.

The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques.

The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).

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Key information

Conditions

Vaginosis, Bacterial Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Antoine BECLERE, Clamart, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pregnant patients aged more than 18 years and more than 14 weeks of gestation but less than 28 weeks.
Multiple pregnancy won't be included.
Patient with a risk of premature delivery with a short cervix or a cervix measured at less than 25 mm (measure done by vaginal ultrasound of the cervix).
Or patient with a past of premature delivery and/or of late abortion.
Symptomatic or asymptomatic patient.
Patients consulting for pregnancy follow up or hospitalized in a unit of Gynecology and Obstetrics involved in the study.
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written informed consent

Exclusion criteria

antecedents : treated hypertension, Foetal malformation, APLS known, diabetes, renal disease, SLE
treated with antibiotics the inclusion's day
dropping consent.

Treatment and study plan

cervical smear

Procedure

biological analysis

Primary outcomes

identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2013
First posted: Jun 11, 2007
Registry last updated: Aug 28, 2014

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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Completed