Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Time to next pregnancy
研究概览
简要总结
Rationale: Elective immediate dilation and curettage (D&C) for miscarriage is associated with the occurrence of intrauterine adhesions (IUA). IUAs may be associated with subsequent subfertility and premature birth. Recent studies have shown that in women with miscarriage, medical treatment (misoprostol/mifepristone) is an effective alternative for curettage. A problem with medication and expectant management is that after initial treatment, sonographic findings during follow-up frequently show incomplete evacuation of uterine retained products of conception (RPOC), which often lead to additional interventions or expectant time-consuming management limiting the benefits of medical treatment.
Objective: To assess, in women with a wish for immediate future pregnancy and RPOC after non-surgical management of a miscarriage, as diagnosed with sonography, the effects of operative hysteroscopy versus expectant management.
Study design: Multicenter randomized clinical trial. Study population: Patients after non-surgical management of a miscarriage with sonographic evidence of RPOC at the follow-up visit 6 weeks after initial treatment and wish for immediate (within 6 months) future pregnancy.
Intervention: operative hysteroscopy versus expectant management. Main study parameters/endpoints: The primary outcome is time to next pregnancy, as substantiated by a positive urinary or serum hCG test. Secondary outcomes are Quality of Life (QOL) scores assessed with the SF-36, HADS and EQ-5D-5L, the need for additional and/or unscheduled treatments and/or visits and complications. Furthermore, data on the course of pregnancy - including miscarriage, ectopic pregnancy and live birth - are documented in those women who have an ongoing pregnancy after randomization during the study follow up period. In addition, iMTA PCQ questionnaires and health-costs are measured in all patients to perform a cost-effectiveness analysis.
A total of 244 (122 per arm) women will be sufficient to answer the questions on the primary endpoint.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women participating in the study will be asked to fill out questionnaires at baseline, 8 weeks and 6 months after randomization. We don not expect specific risks as a result of either the intervention or expectant management.
详细描述
Design : RCT
- Multicenter
- Randomized controlled
- Parallel group design
- Superiority trial
- Non-blinded
Primary Objective
To compare the effectiveness in terms of time to next pregnancy between operative hysteroscopy and expectant management in patients with sonographic evidence of RPOC after primary non-surgical management of miscarriage.
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients after first trimester miscarriage treated non-surgically with sonographic evidence for the presence of RPOC at follow-up visit after 6 weeks (± 1 week) who have an immediate future pregnancy wish and are willing to give informed consent.
排除标准
- •Women aged below 18 years
- •Women aged over 39 years
- •Women not wanting to achieve pregnancy within the first 6 months after non-surgical treatment for miscarriage
- •Women with a history of repeated miscarriage defined as 3 or more consecutive pregnancy losses before 20 weeks of pregnancy duration
- •Women with untreated and/or untreatable subfertility
- •Women presenting with severe uterine bleeding, defined as uterine bleeding that needs acute intervention on medical grounds
- •Women presenting with severe abdominal pain, defined as abdominal pain that needs acute intervention on medical grounds
- •Women with fever (> 38.5° Celsius) or sepsis requiring antibiotic treatment. For the definition of 'sepsis' we refer to the Third International Consensus definitions for Sepsis and Septic Shock (Singer 2016)
- •Women with a contraindication for (office) operative hysteroscopy
- •Women with a failed non-surgical management for miscarriage, as substantiated by the sonographic finding of an intact gestational sac still in situ
- •Women with a congenital uterine anomaly
- •Known cervical stenosis making safe uterine access impossible
- •Visual or pathological (e.g. on biopsy) evidence of malignancy
研究组 & 干预措施
EXPECTANT MANAGEMENT
No treatment will be offered.
干预措施: Expectant management (Other)
OPERATIVE HYSTEROSCOPY
Operative hysteroscopy using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) is performed.
干预措施: Operative hysteroscopy (Procedure)
结局指标
主要结局
Time to next pregnancy
时间窗: up to 3 years after the start of the trial
The primary endpoint is the time until next pregnancy since randomization, with pregnancy defined as a positive urinary or serum hCG test. Patients are asked to contact the study team in case of pregnancy. If a participant has failed to contact the center, pregnancy will be asked at same time as the questionnaires and then once every 6 months as well as at the end of the study by telephone contact or e-mail.
次要结局
- Course of pregnancy(up to 3 years after the start of the trial)
- Out-of-protocol/unscheduled visits(until 6 months after randomisation)
- Necessity for additional treatment(until 6 months after randomisation)
- Health related costs(until 6 months after randomisation)
- Quality Of Life (QOL)(at baseline, 8 weeks after randomization and 6 months after randomization)
- Complications(until 6 months after randomisation)