Hysteroscopy Versus Endouterine Aspiration in the Management of Trophoblastic Retention: A Prospective Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Uterine vacuity
研究概览
简要总结
Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists.
Aim: The main objective is to compare the efficacy of management by endo-uterine aspiration vs. management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound.
Methods: This is a prospective, multicenter, randomized, open-label, two-arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage.
Patients will be randomized (110 per arm) after verification of eligibility criteria and signature of consent, on the day of the operation:
- Arm A: 110 patients treated by operative hysteroscopy
- Arm B: 110 patients treated by endo-uterine aspiration
详细描述
Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists.
Aim: The main objective is to compare the efficacy of management by endo-uterine aspiration versus management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound.
The secondary objectives are:
- the comparison of the rate of complications of the two techniques, during and after surgery
- the comparison of the rate of recourse to a second line surgical management between the two arms,
- the comparison of the rate of synechiae diagnosed by hysterosonography between the two techniques at 6 weeks after surgery,
- the comparison of the time to conception in the two arms during the 2 years after surgery
- the comparison of the fertility rate at 2 years after surgery in the two arms.
Methods: This is a prospective, multicenter, randomized, open-label, two-arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage.
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
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Management for trophoblastic retention after early spontaneous miscarriage (<14 weeks of amenorrhea)
- •Diagnosis of intrauterine trophoblastic retention by endovaginal pelvic ultrasound
- •Shared decision for surgical management
排除标准
- •Known uterine malformation
- •Patient who has received surgical treatment for current intrauterine retention
- •Patient with an intrauterine device (IUD)
- •Pregnancy obtained by medically assisted procreation
- •Indication for emergency surgical management for haemostatic purposes
- •Failure to obtain free, informed and written consent after a period of reflection
- •Person not affiliated or beneficiary of a national health insurance system
- •Person protected by law, under guardianship or curatorship
- •Person participating in other interventional research involving the human person
研究组 & 干预措施
Arm A: Hysteroscopy
Patients randomized to the hysteroscopy arm will receive misoprostol antibiotic prophylaxis to dilate the cervix before surgery, and anti-adhesion barrier gels will be used, according to routine procedures at each center. In case of intrauterine retention complicated by endometritis, antibiotic treatment for 48 hours (penicillin, metronidazole, fluoroquinolones or a combination of these antibiotics) will be administered according to the standard practice of each center. Evacuated retention product will be sent for pathological examination. Rh-negative women will receive prophylaxis to prevent Rh alloimmunization.
干预措施: hysteroscopy (Procedure)
Arm B: Aspiration
Patients randomized to the aspiration arm will receive misoprostol antibiotic prophylaxis to dilate the cervix before surgery and anti-adhesion barrier gels will be used, according to routine procedures at each center. In case of intrauterine retention complicated by endometritis, antibiotic treatment for 48 hours (penicillin, metronidazole, fluoroquinolones or a combination of these antibiotics) will be administered according to the standard practice of each center. Evacuated retention product will be sent for pathological examination. Rh-negative women will receive prophylaxis to prevent Rh alloimmunization.
干预措施: Aspiration (Procedure)
结局指标
主要结局
Uterine vacuity
时间窗: 6 weeks after surgery
Uterine vacuity will be determined by endovaginal pelvic ultrasound. The endovaginal pelvic ultrasound will be performed by an investigator blinded to the patient's group, in order to minimize bias. It will be performed according to a standard pelvic ultrasound technique: a sagittal section and a transverse section passing through the widest part of the uterine body. Uterine vacuity will be defined by a thickness of the mucosa on a sagittal section of 15 mm or less and the absence of a heterogeneous intrauterine mass
次要结局
- Difference between the two arms in the rate of second line surgical management(During surgery)
- Difference between the two arms in mean time to conception(6, 12 and 24 months after surgery)
- Difference between the two arms in synechia rates(6 weeks after surgery)
- Difference between the two arms in complication rates(During surgery and 6 weeks after surgery)
- Difference between the two arms in pregnancy rates(6, 12 and 24 months after surgery)