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
NCT ID: NCT07206342
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2026-01-01
2028-12-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Bordeaux
OTHER
University Hospital, Clermont-Ferrand
OTHER
Centre Hospitalier Universitaire Saint Etienne, France, 43055
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Julien Ghelfi
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble Alpes
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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McCracken G, Houston P, Lefebvre G; Society of Obstetricians and Gynecologists of Canada. Guideline for the management of postoperative nausea and vomiting. J Obstet Gynaecol Can. 2008 Jul;30(7):600-7, 608-16. doi: 10.1016/s1701-2163(16)32895-x. English, French.
Huchon C, Drioueche H, Koskas M, Agostini A, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Panel P, Raiffort C, Giraudet G, Bussieres L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1197-1205. doi: 10.1001/jama.2023.3415.
Kimura Y, Osuga K, Nagai K, Hongyo H, Tanaka K, Ono Y, Higashihara H, Matsuzaki S, Endo M, Kimura T, Tomiyama N. The efficacy of uterine artery embolization with gelatin sponge for retained products of conception with bleeding and future pregnancy outcomes. CVIR Endovasc. 2020 Feb 12;3(1):13. doi: 10.1186/s42155-020-00107-4.
Mathieu E, Riethmuller D, Delouche A, Sicot M, Teyssier Y, Finas M, Guillaume B, Thony F, Ferretti G, Ghelfi J. Management of Symptomatic Vascularized Retained Products of Conception by Proximal Uterine Artery Embolization with Gelatin Sponge Torpedoes. J Vasc Interv Radiol. 2022 Nov;33(11):1313-1320. doi: 10.1016/j.jvir.2022.07.018. Epub 2022 Jul 19.
Deans R, Abbott J. Review of intrauterine adhesions. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):555-69. doi: 10.1016/j.jmig.2010.04.016. Epub 2010 Jul 24.
Tam WH, Lau WC, Cheung LP, Yuen PM, Chung TK. Intrauterine adhesions after conservative and surgical management of spontaneous abortion. J Am Assoc Gynecol Laparosc. 2002 May;9(2):182-5. doi: 10.1016/s1074-3804(05)60129-6.
Gilbert A, Thubert T, Dochez V, Riteau AS, Ducloyer M, Ragot P, Frampas E, Douane F, David A. Angiographic findings and outcomes after embolization of patients with suspected postabortion uterine arteriovenous fistula. J Gynecol Obstet Hum Reprod. 2021 Sep;50(7):102033. doi: 10.1016/j.jogoh.2020.102033. Epub 2020 Dec 7.
Camacho A, Ahn EH, Appel E, Boos J, Nguyen Q, Justaniah AI, Faintuch S, Ahmed M, Brook OR. Uterine Artery Embolization with Gelfoam for Acquired Symptomatic Uterine Arteriovenous Shunting. J Vasc Interv Radiol. 2019 Nov;30(11):1750-1758. doi: 10.1016/j.jvir.2019.04.002. Epub 2019 Aug 10.
Vyas S, Choi HH, Whetstone S, Jha P, Poder L, Shum DJ. Ultrasound features help identify patients who can undergo noninvasive management for suspected retained products of conception: a single institutional experience. Abdom Radiol (NY). 2021 Jun;46(6):2729-2739. doi: 10.1007/s00261-020-02948-y. Epub 2021 Jan 18.
Timmerman D, Wauters J, Van Calenbergh S, Van Schoubroeck D, Maleux G, Van Den Bosch T, Spitz B. Color Doppler imaging is a valuable tool for the diagnosis and management of uterine vascular malformations. Ultrasound Obstet Gynecol. 2003 Jun;21(6):570-7. doi: 10.1002/uog.159.
Kamaya A, Petrovitch I, Chen B, Frederick CE, Jeffrey RB. Retained products of conception: spectrum of color Doppler findings. J Ultrasound Med. 2009 Aug;28(8):1031-41. doi: 10.7863/jum.2009.28.8.1031.
Foreste V, Gallo A, Manzi A, Riccardi C, Carugno J, Sardo ADS. Hysteroscopy and Retained Products of Conception: An Update. Gynecol Minim Invasive Ther. 2021 Nov 5;10(4):203-209. doi: 10.4103/GMIT.GMIT_125_20. eCollection 2021 Oct-Dec.
Quenby S, Gallos ID, Dhillon-Smith RK, Podesek M, Stephenson MD, Fisher J, Brosens JJ, Brewin J, Ramhorst R, Lucas ES, McCoy RC, Anderson R, Daher S, Regan L, Al-Memar M, Bourne T, MacIntyre DA, Rai R, Christiansen OB, Sugiura-Ogasawara M, Odendaal J, Devall AJ, Bennett PR, Petrou S, Coomarasamy A. Miscarriage matters: the epidemiological, physical, psychological, and economic costs of early pregnancy loss. Lancet. 2021 May 1;397(10285):1658-1667. doi: 10.1016/S0140-6736(21)00682-6. Epub 2021 Apr 27.
Other Identifiers
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38RC24.0406
Identifier Type: -
Identifier Source: org_study_id
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