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NOT YET RECRUITING
NCT07206342
NA

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

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-01-01

Completion Date

2028-12-31

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

PROCEDURE

embolization therapy

Patients will undergo embolization alone, which involves temporarily blocking the uterine artery or arteries supplying a hypervascular abnormality using resorbable gelatin fragments.

PROCEDURE

embolization followed by aspiration

Patients will undergo embolization prior to endometrial aspiration. Embolization will be performed in the same manner as in group "Embolization alone" but will be followed within 48 hours by a second procedure to remove the intrauterine residue that will have been devascularized (= deprived of blood) by the embolization.

Locations (4)

CHU de Bordeaux

Bordeaux, France

CHU de Clermont-Ferrand-Gabriel Montpied

Clermont-Ferrand, France

CHU Grenoble Alpes

Grenoble, France

CHU de St Etienne-Hôpital Nord

Saint-Etienne, France