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

NCT07206342 | Not Yet Recruiting

• 1 other identifier: 38RC24.0406
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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

Conditions

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

Keywords

abnormalities vascular uterine; embolization; intrauterine retention; hemorrhage; uterine artery embolization; vaginal bleedings; hysterectomy; uterine hemorrhage; embolization, therapeutic

Outcome Measures

Primary Outcomes (1)

• Clinical success post-procedure as assessed by Doppler-ultrasound

  The primary endpoint is clinical success defined by a null uterine cavity on follow-up Doppler ultrasound and no persistent or recurrent bleeding requiring a new procedure

  From baseline to 3 months after procedure

Secondary Outcomes (7)

• Persistence or recurrence of bleeding at 1 month follow-up in both groups.

  From baseline to 1 month

• Safety of both treatments

  Fom intervention to 90 days after

• the effectiveness of embolization alone compared to embolization followed by uterine evacuation at 1 month after procedure

  From intervention to 1 month

• the effectiveness of embolization alone compared to embolization followed by uterine evacuation at 3 months after procedure

  From intervention to 3 months

• the impact of embolization alone compared to embolization followed by aspiration on the resumption of the menstrual cycle

  From intervention to 12 months

Study Arms (2)

embolization therapy

EXPERIMENTAL

Patients will undergo embolization alone, which involves temporarily blocking the uterine artery or arteries supplying a hypervascular abnormality using resorbable gelatin fragments.

Procedure: embolization therapy

Embolization followed by aspiration

ACTIVE COMPARATOR

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.

Procedure: embolization followed by aspiration

Interventions

embolization therapy PROCEDURE

Patients will undergo embolization alone, which involves temporarily blocking the uterine artery or arteries supplying a hypervascular abnormality using resorbable gelatin fragments.

Also known as: embolic agent

embolization therapy

embolization followed by aspiration PROCEDURE

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.

Also known as: endometrial aspiration, intrauterine aspiration, hysteroscopy

Embolization followed by aspiration

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 cannot be contacted in an emergency
• Participation in other interventional studies during the study period

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Hospital, Bordeaux: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Centre Hospitalier Universitaire Saint Etienne, France, 43055: collaborator

Study Sites (4)

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Clermont-Ferrand-Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

CHU Grenoble Alpes

Grenoble, 38000, France

Location

CHU de St Etienne-Hôpital Nord

Saint-Etienne, 42000, France

Location

Related Publications (13)

• 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.

  PMID: 18644183 BACKGROUND

• 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.

  PMID: 37039805 BACKGROUND

• 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.

  PMID: 32052234 BACKGROUND

• 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.

  PMID: 35868595 BACKGROUND

• 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.

  PMID: 20656564 BACKGROUND

• 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.

  PMID: 11960045 BACKGROUND

• 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.

  PMID: 33301980 BACKGROUND

• 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.

  PMID: 31409569 BACKGROUND

• 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.

  PMID: 33459841 BACKGROUND

• 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.

  PMID: 12808674 BACKGROUND

• 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.

  PMID: 19643786 BACKGROUND

• 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.

  PMID: 34909376 BACKGROUND

• 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.

  PMID: 33915094 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Uterine Anomalies; Uterine Hemorrhage

Interventions

Embolization, Therapeutic; ethylene-vinyl alcohol copolymer; Hysteroscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Julien Ghelfi

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Faure

CONTACT

0476766872; MFaure6@chu-grenoble.fr

AyseGul Sahan

CONTACT

0476766872; agsahan@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the radiologist who performs the ultrasounds will be blinded to the evaluation of the primary judgment criterion (he will not have information regarding the group assigned to the patient).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)