Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

Vaginosis, Bacterial Clinical Trial

Official title:

Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484653
• Other study ID #: 2007/07
• 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

• Vaginosis, Bacterial

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