Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
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Purpose
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 |
|---|---|
| Vaginosis, Bacterial | Procedure: cervical smear |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman |
- identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies [ Time Frame: 24 months ]
| Enrollment: | 1000 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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Procedure: cervical smear
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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
| France | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT00484653 History of Changes |
| Other Study ID Numbers: |
2007/07 |
| First Submitted: | June 8, 2007 |
| First Posted: | June 11, 2007 |
| Last Update Posted: | August 28, 2014 |
| Last Verified: | August 2014 |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities |
Additional relevant MeSH terms:
|
Vaginosis, Bacterial Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female |