Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00484653|
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : August 28, 2014
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 or disease||Intervention/treatment||Phase|
|Vaginosis, Bacterial||Procedure: cervical smear||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
- Procedure: cervical smear
- identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484653
|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|
|Principal Investigator:||Florence BRETELLE, PU-PH||Assistance Publique Hôpitaux de Marseille|