MedTrace Logo

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

NCT07206342 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-10-03

No results posted yet for this study

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

Conditions

  • Hemorrhage, Obstetric
  • Uterine Abnormality
  • Uterine Artery Embolization
  • Vaginal Bleeding During Pregnancy
  • Vaginal Bleeding

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    collaborator OTHER

  • Centre Hospitalier Universitaire Saint Etienne, France, 43055

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Julien Ghelfi · CHU Grenoble Alpes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-03-01
Completion
2028-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206342 on ClinicalTrials.gov