Evaluation of the Non-inferiority of Resorbable Gelatin Embolization Compared to Embolization Com… (NCT07206342) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
France110 participantsStarted 2026-01-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical success post-procedure as assessed by Doppler-ultrasound
Timeframe: From baseline to 3 months after procedure