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Sponsored by: |
Assistance Publique Hopitaux De Marseille |
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Information provided by: | Assistance Publique Hopitaux De Marseille |
ClinicalTrials.gov Identifier: | NCT00484653 |
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 |
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Vaginosis, Bacterial |
Procedure: cervical smear |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman |
Estimated Enrollment: | 1000 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Florence BRETELLE, PU-PH | + 33 4 91 96 46 70 | florence.bretelle@mail.ap-hm.fr |
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 | Recruiting |
POISSY, France, 78303 | |
Contact: Patrick ROZENBERG, PH +33 1 39 27 52 57 | |
Hôpital Saint Joseph | Recruiting |
MARSEILLE, France, 13008 | |
Contact: Alain PASCAL, PH + 33 4 91 80 65 00 | |
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 | |
Centre médicochirurgical et obstétrical | Recruiting |
SCHILTIGHEIM, France, 67303 | |
Contact: Christophe VAYSSIERE, PH + 33 3 88 12 80 00 vayssierec@club-internet.fr |
Principal Investigator: | Florence BRETELLE, PU-PH | Assistance Publique Hôpitaux de Marseille |
Responsible Party: | Assistance Publique Hopitaux De Marseille ( Pr Bretelle Florence ) |
Study ID Numbers: | 2007/07 |
Study First Received: | June 8, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00484653 |
Health Authority: | France: Ministry of Health |
To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial |
Vaginitis Vaginal Diseases Congenital Abnormalities |