Clinical Trial

Evaluation of the Non-inferiority of Resorbable Gelatin Embolization Compared to Embolization Combined With Endometrial Aspiration for the Management of Hemorrhagic Uterine Vascular Abnormalities Following Premature Termination of Pregnancy

Study acronym: NIEMBUT
Not Yet Recruiting
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Summary
The goal of this clinical trial is to determine the best treatment for patients who experience vaginal bleeding following a premature termination of pregnancy. The main questions it aims to answer are: * Evaluate the effectiveness of embolization alone versus embolization followed by aspiration in stopping bleeding * Evaluate its effectiveness in restoring the menstrual cycle. * What are the complications associated with the two procedures? * What is their impact on future fertility? The researchers will evaluate the patients over a period of 12 months. Participants will: * Undergo one of the two procedures (procedure 1: embolization alone and procedure 2: embolization combined with aspiration). * Will participate in regular follow-ups to monitor the risk of recurrence of -bleeding and complications associated with the two treatments * Will undergo imaging tests to assess the persistence of bleeding after the procedure
Trial Details
NCT Number NCT07206342
Lead Sponsor University Hospital, Grenoble
Collaborators: University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire Saint Etienne, France, 43055
Conditions Hemorrhage, Obstetric, Uterine Abnormality, Uterine Artery Embolization, Vaginal Bleeding During Pregnancy, Vaginal Bleeding
Enrollment 110 participants
Start Date 2026-01-01
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-03