Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- Incremental cost-utility ratio (ICUR)
研究概览
简要总结
The ASPIR study aims to evaluate the cost-utility of outpatient manual vacuum aspiration compared with operating room electric aspiration for the management of first-trimester miscarriage. It is hypothesized that manual aspiration will demonstrate equivalent clinical efficacy and patient quality of life while reducing healthcare costs.
详细描述
Miscarriage occurs in approximately 15% of pregnancies during the first trimester. In France, surgical management usually involves electric aspiration in the operating room under anesthesia, associated with hospital admission. Manual vacuum aspiration (MVA) is widely used in low-resource settings and for induced abortion, with demonstrated safety and patient satisfaction. This multicenter randomized controlled trial compares outpatient MVA under local anesthesia and inhaled analgesia versus electric aspiration (EA) under anesthesia in the operating room.
The primary objective is to assess the incremental cost-utility ratio (ICUR, cost per QALY) at 3 months. Secondary outcomes include complications, pain, satisfaction, quality of life, and fertility at 12 months. The study anticipates enrolling 860 participants across multiple centers in France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-44 years
- •Ultrasound-confirmed first-trimester miscarriage requiring surgical management
- •Gestational age between 5 and 12 weeks of amenorrhea
- •Incomplete spontaneous abortion or ongoing non-viable pregnancy
- •Patient able to provide oral informed consent
排除标准
- •Complete expulsion of pregnancy (endometrial thickness < 15 mm)
- •Choice of medical treatment with misoprostol
- •Elective termination of pregnancy
- •Unwanted pregnancy
- •Pregnancy of unknown location, molar pregnancy
- •Known uterine malformation
- •Prior surgical aspiration for the current pregnancy
- •Intrauterine device in place
- •Contraindicating medications (e.g. anticoagulants)
- •Protected adults (under guardianship)
- •Inability to complete study questionnaires
- •Lack of social security coverage
- •Haemorrhagic miscarriage
结局指标
主要结局
Incremental cost-utility ratio (ICUR)
时间窗: 3 months
Incremental cost per quality-adjusted life year (QALY) gained of outpatient MVA compared to operating room EA, from a collective perspective.
次要结局
- Annual net financial benefit for health insurance over up to 5 years of different development scenarios for manual vacuum aspiration in consultation for the management of pregnancies terminated before 12 weeks of gestation(up to 5 years)
- To compare the two management strategies in terms of success and intraoperative and postoperative complications(1 month)
- To assess patient satisfaction(day 1 and 2)
- To compare the two strategies (electric suction versus manual vacuum kit suction)(days 0, 1,7 and 1 and 3 months)
- The risk factors for failure(3 months)
- Satisfaction with the patient's care by medical staff(day 0 and 1 month)
- Patient having been pregnant in days(12 months)
- To assess patient satisfaction(day 1 and 2 and 1 month et 3 month)
- To assess patient satisfaction(1 and 3 months)
- To compare the two strategies (electric suction versus manual vacuum kit suction)(Day 0, 1,7 and 1 and 3 months)
- To compare the two strategies (electric suction versus manual vacuum kit suction)(Day 0 to 7)
- To compare the two strategies (electric suction versus manual vacuum kit suction)(Day 0)
- To compare the two strategies (electric suction versus manual vacuum kit suction)(1 and 3 months)
- To compare the two strategies (electric suction versus manual vacuum kit suction)(1 et 3 months)