Clinical trial NCT00484653: Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Official title: Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginosis, Bacterial
Keywords: To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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.

Primary outcomes:
measure: identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: CHU Antoine BECLERE
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Marseille
country: France
facility: Hôpital Nord-OB/GYN Department
city: Marseille
country: France
facility: Hôpital de la Conception
city: Poissy
country: France
facility: Centre Hospitalier Poissy-Saint-Germain
city: Schiltigheim
country: France
facility: Centre médicochirurgical et obstétrical
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Florence BRETELLE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.