Hemorrhage, ObstetricNIEMBUTNCT07206342
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
A study testing embolization therapy and embolization followed by aspiration in people with Hemorrhage, Obstetric and Uterine Abnormality, run by University Hospital, Grenoble at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemorrhage, Obstetric, Uterine Abnormality, Uterine Artery Embolization
- What is being tested?
- embolization therapy and embolization followed by aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
CHU de Bordeaux
Bordeaux, 33000
Carole Guezou, 0557874560, carole.guezou@chu-bordeaux.fr
Clement Marcelin
CHU de Clermont-Ferrand-Gabriel Montpied
Clermont-Ferrand, 63000
Pascal Chabrot, 0473751736, pchabrot@chu-clermontferrand.fr
Pascal Chabrot
CHU Grenoble Alpes
Grenoble, 38000
Julien Ghelfi, 0476768909, jghelfi@chu-grenoble.fr
AyseGul Sahan, 0476766872, agsahan@chu-grenoble.fr
CHU de St Etienne-Hôpital Nord
Saint-Etienne, 42000
Remi Grange, 0477828963, remi.grange@chu-st-etienne.fr
Remi Grange
About this study
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:
Read more
- 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
Read the 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 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.
- Conditions
- Hemorrhage, Obstetric, Uterine Abnormality, Uterine Artery Embolization, Vaginal Bleeding During Pregnancy, Vaginal Bleeding
- Being tested
- embolization therapy, embolization followed by aspiration
- Keywords
- abnormalities vascular uterine, embolization, intrauterine retention, hemorrhage, uterine artery embolization, vaginal bleedings, hysterectomy, uterine hemorrhage, embolization, therapeutic
- Medical subject headings
- Hemorrhage, Uterine Anomalies, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization therapyProcedure or surgery
Also called embolic agent
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 aspirationProcedure or surgery
Also called endometrial aspiration, intrauterine aspiration, hysteroscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: embolization followed by aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 3 months after procedure
Secondary outcomes (7)
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.
Measured: From baseline to 1 month
Safety of both treatments
Complications attributable to procedures within 90 days of admission according to the Clavien-Dindo classification
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From intervention to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage, ObstetricStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire Saint Etienne, France, 43055
- Responsible party
- Sponsor
- Investigators
- Julien Ghelfi, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206342
- Sponsor's protocol ID
- 38RC24.0406
- Acronym
- NIEMBUT
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18644183Huchon 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.
PubMed 37039805Kimura 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.
PubMed 32052234Vyas 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.
PubMed 33459841Timmerman 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.
PubMed 12808674Kamaya 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.
PubMed 19643786Quenby 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.
PubMed 33915094Mathieu 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.
PubMed 35868595Deans 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.
PubMed 20656564Tam 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.
PubMed 11960045Gilbert 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.
PubMed 33301980Camacho 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.
PubMed 31409569Foreste 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.
PubMed 34909376
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07206342
- Acronym / sponsor ID
- NIEMBUT / 38RC24.0406
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire Saint Etienne, France, 43055
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| embolization therapy | Experimental | Procedure: embolization therapyPatients 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 | Procedure: embolization followed by aspirationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolization therapyAlso: embolic agentPatients will undergo embolization alone, which involves temporarily blocking the uterine artery or arteries supplying a hypervascular abnormality using resorbable gelatin fragments. | Procedure or surgery | embolization therapy |
| embolization followed by aspirationAlso: endometrial aspiration, intrauterine aspiration, hysteroscopyPatients 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 or surgery | Embolization followed by aspiration |
Primary outcome
Clinical success post-procedure as assessed by Doppler-ultrasound
Time frame: From baseline to 3 months after procedure
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
7 secondary outcomes
Persistence or recurrence of bleeding at 1 month follow-up in both groups.
Time frame: From baseline to 1 month
Safety of both treatments
Time frame: Fom intervention to 90 days after
the effectiveness of embolization alone compared to embolization followed by uterine evacuation at 1 month after procedure
Time frame: From intervention to 1 month
the effectiveness of embolization alone compared to embolization followed by uterine evacuation at 3 months after procedure
Time frame: From intervention to 3 months
the impact of embolization alone compared to embolization followed by aspiration on the resumption of the menstrual cycle
Time frame: From intervention to 12 months
the impact of embolization alone versus embolization followed by aspiration on subsequent fertility
Time frame: From intervention to 12 months
If infertility diagnosis within 12 months, the rate of synechiae found between the two groups.
Time frame: From intervention to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 18644183McCracken 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.
- Background: PubMed 37039805Huchon 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.
- Background: PubMed 32052234Kimura 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.
- Background: PubMed 33459841Vyas 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.
- Background: PubMed 12808674Timmerman 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.
- Background: PubMed 19643786Kamaya 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.
- Background: PubMed 33915094Quenby 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.
- Results publication: PubMed 35868595Mathieu 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.
- Results publication: PubMed 20656564Deans 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.
- Results publication: PubMed 11960045Tam 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.
- Results publication: PubMed 33301980Gilbert 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.
- Results publication: PubMed 31409569Camacho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien Ghelfi principal investigator
CHU Grenoble Alpes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embolization therapy and embolization followed by aspiration in people with Hemorrhage, Obstetric and Uterine Abnormality, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine Faure (0476766872, MFaure6@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success post-procedure as assessed by Doppler-ultrasound (time frame: From baseline to 3 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07206342, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.