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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00484653
Other study ID # 2007/07
Secondary ID
Status Completed
Phase N/A
First received June 8, 2007
Last updated August 27, 2014
Start date July 2007
Est. completion date July 2013

Study information

Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
cervical smear
biological analysis

Locations

Country Name City State
France CHU Antoine BECLERE Clamart
France Hôpital de la Conception Marseille
France Hôpital Nord-OB/GYN Department Marseille
France Hôpital Saint Joseph Marseille
France Centre Hospitalier Poissy-Saint-Germain Poissy
France Centre médicochirurgical et obstétrical Schiltigheim

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies 24 months No
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