Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Primary Purpose
Vaginosis, Bacterial
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cervical smear
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginosis, Bacterial focused on measuring To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities
Eligibility 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.
Sites / Locations
- CHU Antoine BECLERE
- Hôpital Saint Joseph
- Hôpital Nord-OB/GYN Department
- Hôpital de la Conception
- Centre Hospitalier Poissy-Saint-Germain
- Centre médicochirurgical et obstétrical
Outcomes
Primary Outcome Measures
identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies
Secondary Outcome Measures
Full Information
NCT ID
NCT00484653
First Posted
June 8, 2007
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT00484653
Brief Title
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Official Title
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Bacterial
Keywords
To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
cervical smear
Intervention Description
biological analysis
Primary Outcome Measure Information:
Title
identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence BRETELLE, PU-PH
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Antoine BECLERE
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hôpital Nord-OB/GYN Department
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Poissy-Saint-Germain
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
Centre médicochirurgical et obstétrical
City
Schiltigheim
ZIP/Postal Code
67303
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25452591
Citation
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.
Results Reference
derived
PubMed Identifier
21789604
Citation
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.
Results Reference
derived
PubMed Identifier
20027045
Citation
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):134-140. doi: 10.1097/AOG.0b013e3181c391d7.
Results Reference
derived
Learn more about this trial
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
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