Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
University Hospital, Bordeaux
University Hospital, Clermont-Ferrand
Conditions:
Hemorrhage, Obstetric
Uterine Abnormality
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ar...
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 orde...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07206342
Start Date
January 1 2026
End Date
December 31 2028
Last Update
October 3 2025
Active Locations (4)
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1
CHU de Bordeaux
Bordeaux, France, 33000
2
CHU de Clermont-Ferrand-Gabriel Montpied
Clermont-Ferrand, France, 63000
3
CHU Grenoble Alpes
Grenoble, France, 38000
4
CHU de St Etienne-Hôpital Nord
Saint-Etienne, France, 42000