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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Clinical success post-procedure as assessed by Doppler-ultrasound
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 in the exclusion period of another study
- •Patient cannot be contacted in an emergency
- •Participation in other interventional studies during the study period
研究组 & 干预措施
embolization therapy
Patients will undergo embolization alone, which involves temporarily blocking the uterine artery or arteries supplying a hypervascular abnormality using resorbable gelatin fragments.
干预措施: embolization therapy (Procedure)
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.
干预措施: embolization followed by aspiration (Procedure)
结局指标
主要结局
Clinical success post-procedure as assessed by Doppler-ultrasound
时间窗: 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
次要结局
- Persistence or recurrence of bleeding at 1 month follow-up in both groups.(From baseline to 1 month)
- the impact of embolization alone compared to embolization followed by aspiration on the resumption of the menstrual cycle(From intervention to 12 months)
- 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 versus embolization followed by aspiration on subsequent fertility(From intervention to 12 months)
- If infertility diagnosis within 12 months, the rate of synechiae found between the two groups.(From intervention to 12 months)