Skip to content

Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00484653
Enrollment
1000
Registered
2007-06-11
Start date
2007-07-31
Completion date
2013-07-31
Last updated
2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginosis, Bacterial

Keywords

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

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).

Interventions

biological analysis

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026