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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 8, 2007 | ||||
| Last Updated Date | January 14, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00484653 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman | ||||
| Official Title ICMJE | Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman | ||||
| 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). |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Open Label, Uncontrolled, Single Group Assignment | ||||
| Condition ICMJE | Vaginosis, Bacterial | ||||
| Intervention ICMJE | Procedure: cervical smear | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00484653 | ||||
| Responsible Party | Pr Bretelle Florence, Assistance Publique Hopitaux De Marseille | ||||
| Study ID Numbers ICMJE | 2007/07 | ||||
| Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique Hopitaux De Marseille | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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