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| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
| Centre Hospitalier Universitaire Saint Etienne, France, 43055 | UNKNOWN |
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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:
The researchers will evaluate the patients over a period of 12 months.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence or recurrence of bleeding at 1 month follow-up in both groups. | Evaluate the effectiveness of embolization alone versus embolization followed by aspiration at 1 month of follow-up in stopping bleeding in patients with hypervascularized hemorrhagic uterine retention following premature termination of pregnancy. | From baseline to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marine Faure | Contact | 0476766872 | MFaure6@chu-grenoble.fr | |
| AyseGul Sahan | Contact | 0476766872 | agsahan@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julien Ghelfi | CHU Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18644183 | Background | 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. | |
| 37039805 | 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. |
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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).
|
| 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. |
|
|
| Safety of both treatments | Complications attributable to procedures within 90 days of admission according to the Clavien-Dindo classification | Fom intervention to 90 days after |
| the effectiveness of embolization alone compared to embolization followed by uterine evacuation at 1 month after procedure | Measurement of uterine emptiness on Doppler ultrasound at 1 month | From intervention to 1 month |
| the effectiveness of embolization alone compared to embolization followed by uterine evacuation at 3 months after procedure | Measurement of uterine emptiness on Doppler ultrasound at 3 months | From intervention to 3 months |
| the impact of embolization alone compared to embolization followed by aspiration on the resumption of the menstrual cycle | Time between intervention and resumption of menstrual cycle | From intervention to 12 months |
| the impact of embolization alone versus embolization followed by aspiration on subsequent fertility | New pregnancy occurring within 12 months of the patient's admission | From intervention to 12 months |
| If infertility diagnosis within 12 months, the rate of synechiae found between the two groups. | Uterine adhesions on hysteroscopy performed for infertility assessment. | From intervention to 12 months |
| CHU de Clermont-Ferrand-Gabriel Montpied | Clermont-Ferrand | 63000 | France |
|
| CHU Grenoble Alpes | Grenoble | 38000 | France |
|
| CHU de St Etienne-Hôpital Nord | Saint-Etienne | 42000 | France |
|
| 32052234 | 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. |
| 33459841 | 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. |
| 12808674 | 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. |
| 19643786 | 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. |
| 33915094 | 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. |
| 35868595 | Result | 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. |
| 20656564 | Result | 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. |
| 11960045 | Result | 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. |
| 33301980 | Result | 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. |
| 31409569 | Result | 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. |
| 34909376 | Result | 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. |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| C562565 | Uterine Anomalies |
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| C020320 | ethylene-vinyl alcohol copolymer |
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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