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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
Patients will undergo embolization alone, which involves temporarily blocking the uterine artery or arteries supplying a hypervascular abnormality using resorbable gelatin fragments.
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.
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
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
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
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
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
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
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
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
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
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