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


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

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Diseases

U.S. FDA Resources

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 ]


Enrollment:	1000
Study Start Date:	July 2007
Study Completion Date:	July 2013
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Intervention Details:

biological analysis

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


France
CHU Antoine BECLERE
Clamart, France, 92140
Hôpital Saint Joseph
Marseille, France, 13008
Hôpital Nord-OB/GYN Department
Marseille, France, 13015
Hôpital de la Conception
Marseille, France, 13385
Centre Hospitalier Poissy-Saint-Germain
Poissy, France, 78303
Centre médicochirurgical et obstétrical
Schiltigheim, France, 67303

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators


Principal Investigator:	Florence BRETELLE, PU-PH	Assistance Publique Hôpitaux de Marseille

More Information

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

Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F; Groupe de Recherche en Obstetrique Gynecologie. High Atopobium vaginae and Gardnerella vaginalis vaginal loads are associated with preterm birth. Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966. Epub 2014 Dec 1.

Menard JP, Fenollar F, Raoult D, Boubli L, Bretelle F. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):513-8. doi: 10.1007/s10096-011-1341-8. Epub 2011 Jul 26.

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. doi: 10.1097/AOG.0b013e3181c391d7.


Responsible Party:	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:	August 27, 2014
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 September 26, 2016