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Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
This study is currently recruiting participants.
Study NCT00484653   Information provided by Assistance Publique Hopitaux De Marseille
First Received: June 8, 2007   Last Updated: January 14, 2009   History of Changes

June 8, 2007
January 14, 2009
July 2007
July 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00484653 on ClinicalTrials.gov Archive Site
 
 
 
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

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).

 
 
Interventional
Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Vaginosis, Bacterial
Procedure: cervical smear
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
 
July 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Florence BRETELLE, PU-PH + 33 4 91 96 46 70 florence.bretelle@mail.ap-hm.fr
France
 
NCT00484653
Pr Bretelle Florence, Assistance Publique Hopitaux De Marseille
2007/07
Assistance Publique Hopitaux De Marseille
 
Principal Investigator: Florence BRETELLE, PU-PH Assistance Publique Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP