Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number of participants with complete evacuation of uterus
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).
The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.
详细描述
Aim: To investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss.
Primary objective: To test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss.
Secondary objectives: To test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. The investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life.
Women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. The participants will be randomized to two groups. First group will receive oral mifepristone (600 mg) and the second group will not. The remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost.
Three weeks after medical treatment, primary and secondary outcomes will be assessed. In case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management
- •Age 18 years and older
- •Intra-uterine pregnancy
- •Hemodynamically stable patient
- •No signs of infection
- •No signs of incomplete miscarriage
- •Willing and able to give informed consent
排除标准
- •Women opting for alternative methods of miscarriage management (expectant or surgical)
- •Diagnosis of incomplete miscarriage
- •Life threatening bleeding
- •Hemodynamically unstable patient
- •Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria
- •Previous participation in this trial
- •Unable to give informed consent
研究组 & 干预措施
Mifepristone and Misoprostol
Patients receive oral mifepristone (600 mg) 48 hours before medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).
干预措施: Mifepristone, Oral, 200 Mg (Drug)
Mifepristone and Misoprostol
Patients receive oral mifepristone (600 mg) 48 hours before medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).
干预措施: Misoprostol Pill (Drug)
Misoprostol
Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).
干预措施: Misoprostol Pill (Drug)
结局指标
主要结局
Number of participants with complete evacuation of uterus
时间窗: Three weeks after randomization
Complete evacuation of uterus will be assessed by clinical and ultrasound examination three weeks after treatment. There should be no vaginal bleeding and no suspicion of retained products of conception on ultrasound scan (endometrial thickness \<= 15 mm) to declare the treatment successful.
次要结局
- Complications(Up to three weeks after randomization)
- Duration of vaginal bleeding(Up to three weeks after randomization)
- Total misoprostol dose used(Up to three weeks after randomization)
- Patient quality of life(At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization)
- Side effects(Up to three weeks after randomization)
- Hemoglobin change(At randomization and three weeks after randomization)
- Indication for surgical treatment(Three weeks after randomization)
- Patient satisfaction(Three weeks after randomization)
研究者
Mate Milas
Principal Investigator
Clinical Hospital Merkur