Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

NCT00484653 | Completed

• 1 other identifier: 2007/07
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

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).

Conditions

Vaginosis, Bacterial

Keywords

To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities

Outcome Measures

Primary Outcomes (1)

• identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies

  24 months

Interventions

cervical smear PROCEDURE

biological analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• antecedents : treated hypertension, Foetal malformation, APLS known, diabetes, renal disease, SLE
• dropping consent.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (6)

CHU Antoine BECLERE

Clamart, 92140, France

Location

Hôpital Saint Joseph

Marseille, 13008, France

Location

Hôpital Nord-OB/GYN Department

Marseille, 13015, France

Location

Hôpital de la Conception

Marseille, 13385, France

Location

Centre Hospitalier Poissy-Saint-Germain

Poissy, 78303, France

Location

Centre médicochirurgical et obstétrical

Schiltigheim, 67303, France

Location

Related Publications (3)

• Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F; Groupe de Recherche en Obstetrique Gynecologie. High Atopobium vaginae and Gardnerella vaginalis vaginal loads are associated with preterm birth. Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966. Epub 2014 Dec 1.

  PMID: 25452591 DERIVED

• Menard JP, Fenollar F, Raoult D, Boubli L, Bretelle F. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):513-8. doi: 10.1007/s10096-011-1341-8. Epub 2011 Jul 26.

  PMID: 21789604 DERIVED

• Menard JP, Mazouni C, Salem-Cherif I, Fenollar F, Raoult D, Boubli L, Gamerre M, Bretelle F. High vaginal concentrations of Atopobium vaginae and Gardnerella vaginalis in women undergoing preterm labor. Obstet Gynecol. 2010 Jan;115(1):134-140. doi: 10.1097/AOG.0b013e3181c391d7.

  PMID: 20027045 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Vaginal Smears

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Florence BRETELLE, PU-PH

  Assistance Publique Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

FR (6)