Status:
COMPLETED
Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Low Risk of Preterm Delivery
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries have no abnormal history. It is widely agreed that preterm delivery is often associated with bacterial vagi...
Detailed Description
The principal objective is to use a cost-effectiveness study to assess the medical and economic impact of a new strategy for the screening and subsequent treatment of vaginal flora anomalies before th...
Eligibility Criteria
Inclusion
- Women over 18 years with a pregnancy before 20 weeks are some parity and gravidity;
- Woman who understood the process and the objectives of the study and who agreed to sign an informed consent;
- Without a history of premature birth or late abortion (population at low risk of preterm birth);
- Having no major risk factors for prematurity: insulin-dependent diabetes, systemic lupus erythematosus, hypertension, uterine malformation, cone biopsy, multiple pregnancy;
- No pre-existing hypertension;
- Asymptomatic or symptomatic regarding the diagnosis of bacterial vaginosis.
Exclusion
- Woman withdrawing her consent during the study
Key Trial Info
Start Date :
March 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2022
Estimated Enrollment :
6800 Patients enrolled
Trial Details
Trial ID
NCT02288832
Start Date
March 6 2015
End Date
October 21 2022
Last Update
April 13 2023
Active Locations (2)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
2
Hôpital Nord Assistance Publique Hôpitaux de Marseille
Marseille, France, 13915