Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484653
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2007-06-08
Brief Title:
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None