ClinicalTrials.gg
Not yet recruitingNCT07206342NIEMBUTUpdated Oct 3, 2025

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

An interventional study of embolization therapy and embolization followed by aspiration in Hemorrhage, Obstetric, Uterine Abnormality and Uterine Artery Embolization, sponsored by University Hospital, Grenoble. Not yet recruiting at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 120 studies in Hemorrhage with a site in France — 25 open to participants now, 31 under way, 4 of them phase 3. Hemorrhage · France.

Planned enrollment
41st of 74
110 · median 150
Started
2026
with 4 others
No phase
35 of 120
11 open now
Primary completion
2028-03
later than 18 of 30 live
Registered
116th of 120
by date
Lead sponsor
5 of 120
University Hospital, Grenoble

Among the 120 studies in Hemorrhage with a site in France, this one is the 41st largest by planned enrollment of the 74 interventional ones that give a count, is one of 5 that started in 2026, is one of 35 with no phase, reaches primary completion later than 18 of the 30 other live ones, and was the 116th registered.

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

Browse Hemorrhage studies →

Open to participants now

25 of the 120 studies in Hemorrhage with a site in France are open now. Recruiting first, the newest first:

20 more — sign in →

All 25 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 170 Hemorrhage studies recruiting now, 109 (64%) set no upper age limit and 40 (24%) stop at 75 or younger; 25 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 120 studies in Hemorrhage with a site in France, or all of them as a file.
02

Study 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
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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion Criteria:

  • Patient presenting to the emergency department with hemorrhagic shock: systolic blood pressure \< 90 mmHg associated with tachycardia > 120 bpm
  • Severe renal failure ( \< 30 mL/min)
  • Medical history of severe allergy to iodinated contrast media
  • Severe coagulation disorders ( \<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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    embolization therapy

    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

  • Active comparator
    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.

    Procedure: embolization followed by aspiration

Interventions

  • Procedureembolization therapy

    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

  • Procedureembolization 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.

    Also known as: endometrial aspiration, intrauterine aspiration, hysteroscopy

06

What researchers measure

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

    Time frame: From baseline to 3 months after procedure

Secondary outcomes

  1. 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.

    Time frame: From baseline to 1 month

  2. Safety of both treatments

    Complications attributable to procedures within 90 days of admission according to the Clavien-Dindo classification

    Time frame: Fom intervention to 90 days after

  3. 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

    Time frame: From intervention to 1 month

  4. 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

    Time frame: From intervention to 3 months

  5. 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

    Time frame: From intervention to 12 months

  6. the impact of embolization alone versus embolization followed by aspiration on subsequent fertility

    New pregnancy occurring within 12 months of the patient's admission

    Time frame: From intervention to 12 months

  7. If infertility diagnosis within 12 months, the rate of synechiae found between the two groups.

    Uterine adhesions on hysteroscopy performed for infertility assessment.

    Time frame: From intervention to 12 months

07

Study locations

4 sites
08

References and documents

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 18644183 ↗
  • 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. PubMed 37039805 ↗
  • 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. PubMed 32052234 ↗
  • 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. PubMed 33459841 ↗
  • 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. PubMed 12808674 ↗
  • 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. PubMed 19643786 ↗
  • 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. PubMed 33915094 ↗
  • 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. PubMed 35868595 ↗
  • 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. PubMed 20656564 ↗
  • 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. PubMed 11960045 ↗
  • 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. PubMed 33301980 ↗
  • 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. PubMed 31409569 ↗
  • 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. PubMed 34909376 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2026; primary completion for Mar 2028, 26 months later.

Of 192 non-industry interventional studies with no phase under Hemorrhage, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 26 months is above that.

Counting every sponsor, half of 227 studies reached it within 19 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2025
First posted
Oct 3, 2025
StartEst.
Jan 1, 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Dec 31, 2028
Last update
Oct 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07206342
Collaborators
University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire Saint Etienne, France, 43055
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 3, 2025

Study contacts

Marine Faure
Contact
MFaure6@chu-grenoble.fr
0476766872
AyseGul Sahan
Contact
agsahan@chu-grenoble.fr
0476766872
Julien Ghelfi
principal investigator · CHU Grenoble Alpes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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