Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Assistance Publique Hopitaux De Marseille. Recruitment status was Recruiting

First Received on June 8, 2007. Last Updated on January 29, 2010 History of Changes

Sponsor:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00484653

Purpose

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).

Condition	Intervention
Vaginosis, Bacterial	Procedure: cervical smear

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

biological analysis

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.
social security cover
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484653

Contacts

Contact: Florence BRETELLE, PU-PH

+ 33 4 91 96 46 70

florence.bretelle@mail.ap-hm.fr

Locations

France
CHU Antoine BECLERE	Recruiting
Clamart, France, 92140
Contact: Marie-Victoire SENAT, PH + 33 1 45 37 44 44 marie-victoire.senat@abc.ap-hop-paris.fr
Hôpital Nord-OB/GYN Department	Recruiting
Marseille, France, 13015
Contact: Florence BRETELLE, PU-PH + 33 4 91 96 46 70 florence.bretelle.@mail.ap-hm.fr
Sub-Investigator: Léon BOUBLI, PU-PH
Hôpital de la Conception	Recruiting
Marseille, France, 13385
Contact: Aubert AGOSTINI, PH + 33 4 91 38 37 85 aubert.agostini@mail.ap-hm.fr
Hôpital Saint Joseph	Recruiting
Marseille, France, 13008
Contact: Alain PASCAL, PH + 33 4 91 80 65 00
Centre Hospitalier Poissy-Saint-Germain	Recruiting
Poissy, France, 78303
Contact: Patrick ROZENBERG, PH +33 1 39 27 52 57
Centre médicochirurgical et obstétrical	Recruiting
Schiltigheim, France, 67303
Contact: Christophe VAYSSIERE, PH + 33 3 88 12 80 00 vayssierec@club-internet.fr

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Florence BRETELLE, PU-PH

Assistance Publique Hôpitaux de Marseille

More Information

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Menard JP, Mazouni C, Salem-Cherif I, Fenollar F, Raoult D, Boubli L, Gamerre M, Bretelle F. High vaginal concentrations of Atopobium vaginae and Gardnerella vaginalis in women undergoing preterm labor. Obstet Gynecol. 2010 Jan;115(1):134-40.

Responsible Party:	Pr Bretelle Florence, Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00484653 History of Changes
Other Study ID Numbers:	2007/07
Study First Received:	June 8, 2007
Last Updated:	January 29, 2010
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique Hopitaux De Marseille:

To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities

Additional relevant MeSH terms:

Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012