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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06349122
Other study ID # 2023-509421-41-00
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date August 2024
Est. completion date January 2028

Study information

Verified date March 2024
Source Assistance Publique Hopitaux De Marseille
Contact Franceline CARTIER
Phone +33491381927
Email promotion.interne@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis. The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth. The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.


Description:

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Study Design


Intervention

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Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of preterm birth The primary endpoint will be the rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group and the standard group. Before 37 weeks of gestation
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