NCT07206342

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Ten to 15% of pregnancies end in the first trimester. Voluntary termination of pregnancy and spontaneous miscarriage, the two main causes of pregnancy loss, are managed medically or surgically in order to remove the intrauterine residue and restore a vacant uterus. In cases of incomplete evacuation, uterine retention may persist in approximately 1% of all pregnancies and up to 40% of pregnancy terminations in the second trimester. The management of uterine retention depends on the clinical presentation and its vascularization on ultrasound. If it is not vascularized or only slightly vascularized, simple aspiration or monitoring is considered. In cases of hypervascularity, treatment is debated given the variable amount of bleeding and the sometimes spontaneously favorable outcome. Doppler criteria (systolic peak velocity, resistance index, or vascular invasion of the myometrium) have been described to select patients who are likely to have a spontaneous favorable outcome from those who require invasive management. In cases of hypervascularized intrauterine retention with negative findings on Doppler ultrasound, performing endometrial aspiration carries a significant risk of severe bleeding during the procedure and is generally preceded by embolization in order to minimize this risk (embolization + aspiration). Aspiration induces adhesions (synechiae) that can impair the patient's future fertility. Recent publications show the effectiveness of temporary embolization alone using resorbable gelatin fragments to stop bleeding. Our team has reported uterine emptiness rates of approximately 75% at 1 month and 95% at 3 months after embolization alone with resorbable gelatin. The objective of this study is therefore to evaluate the non-inferiority of embolization alone with resorbable gelatin compared to embolization followed by endometrial aspiration in patients with hypervascularized and hemorrhagic intrauterine retention following premature termination of pregnancy.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-03-01
• Completion: 2028-12-31
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

4 sites across 1 country: France