Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment

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 Primary Completion Date:	July 2009 (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
	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
	Centre Hospitalier Poissy-Saint-Germain	Not yet recruiting
	POISSY, France, 78303
	Contact: Patrick ROZENBERG, PH +33 1 39 27 52 57
	Hôpital Saint Joseph	Not yet recruiting
	MARSEILLE, France, 13008
	Contact: Alain PASCAL, PH + 33 4 91 80 65 00
	CHU Antoine BECLERE	Not yet recruiting
	CLAMART, France, 92140
	Contact: Marie-Victoire SENAT, PH + 33 1 45 37 44 44 marie-victoire.senat@abc.ap-hop-paris.fr
	Centre médicochirurgical et obstétrical	Not yet 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

Responsible Party:	Assistance Publique Hopitaux De Marseille ( Pr Bretelle Florence )
Study ID Numbers:	2007/07
First Received:	June 8, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00484653
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

Study placed in the following topic categories:

Genital Diseases, Female

Bacterial Infections

Vaginosis, Bacterial

Vaginitis

Vaginal Diseases

Congenital Abnormalities

ClinicalTrials.gov processed this record on October 10, 2008

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