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 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Grenoble

Phase

Not applicable

Started

2026-01-01

Last updated

2025-10-03

Condition(s) studied

Hemorrhage, ObstetricUterine AbnormalityUterine Artery EmbolizationVaginal Bleeding During PregnancyVaginal Bleeding

Investigational drug(s) / intervention(s)

embolization therapyembolization followed by aspiration

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

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.

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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient who experienced a miscarriage within 3 months * Patient with gynecological bleeding * Patient presenting with hypervascularized uterine retention with negative Doppler ultrasound findings (endometrial hypervascularization with 1) systolic peak velocity greater than 70 cm/s and/or 2) resistance index (RI) within the retention \< 0.5) * Patient affiliated to french social security * Patient who has signed the written informed consent form Exclusion Criteria: * Patient presenting to the emergency department with hemorrhagic shock: systolic blood pressure \< 90 mmHg associated with tachycardia \> 120 bpm * Severe renal failure (glomerular filtration rate \< 30 mL/min) * Medical history of severe allergy to iodinated contrast media * Severe coagulation disorders (platelets \<50G/L, PT \< 50%) * Anticoagulant and/or antiplatelet agent that cannot be discontinued a few days before the procedure * Patient referred to in Articles L1121-5, L1121-6, and L1121-8 of the French Public Health Code * Staff with a hierarchical relationship to the principal investigator * Patient in the exclusion period of another study * Patient cannot be contacted in an emergency * Participation in other interventional studies during the study period

Primary outcome measure(s)

Clinical success post-procedure as assessed by Doppler-ultrasound — From baseline to 3 months after procedure
The primary endpoint is clinical success defined by a null uterine cavity on follow-up Doppler ultrasound and no persistent or recurrent bleeding requiring a new procedure

Trial sites (4)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07206342 on ClinicalTrials.gov ↗ ← All trials in France