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ClinicalTrials.gov ID

NCT07206342

Lead Sponsor

University Hospital, GrenobleOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

110Estimated

Last Update Posted

Oct 3, 2025Actual

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

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

Brief 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.

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

• embolization therapy
• embolization followed by aspiration

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University Hospital, GrenobleOTHER

Collaborators

University Hospital, BordeauxOTHER

University Hospital, Clermont-FerrandOTHER

Centre Hospitalier Universitaire Saint Etienne, France, 43055UNKNOWN

jghelfi@chu-grenoble.fr0476768909

remi.grange@chu-st-etienne.fr0477828963