Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion in Young Pregnancy - A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Success rate of complete abortion
研究概览
简要总结
Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. There is little data to compare the efficacy of concomitant administration of both drugs and different time intervals.
This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.
详细描述
Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). According to the original protocol ,the administration of oral Mifepristone 600 mg is followed by oral Misoprostol 400 mcg in an interval of 36 to 48 hours. Shortening this time interval may convince patients to avoid surgical termination of pregnancy, enhance patient's compliance to treatment and even be more economically.
The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. The patients are recommended to have an ultrasound examination after 2 to 3 weeks. There is little data to compare the efficacy of concomitant administration of both drugs according to the dosage of this protocol and different time intervals.
This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.
Participants in the study group will be given both drugs at the same time while participants in the control group will be given Mifepristone and Misoprostol in an interval of 48 hours.
The investigators hypothesis is that administration of both drugs concomitantly will not change significantly the success rate of the procedure and will not enhance the side effects.
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
- •intrauterine singleton pregnancy of less than 49 days, reassured by ultrasound examination
- •patient who desire to terminate their pregnancy and have approval of the committee for termination of pregnancy
- •patient who gave their consent to have a surgical abortion eventual if needed
排除标准
- •contraindication to Mifepristone or Misoprostol
- •suspected ectopic pregnancy
- •systemic treatment with steroids
- •adrenal insufficiency
- •heart and blood vessels disease
- •coagulopathy or use of anti-thrombotic agents
- •uncontrolled asthma
- •liver or kidney insufficiency
- •intrauterine device
- •breastfeeding
研究组 & 干预措施
Intervention
Administration of drugs concomitantly.
干预措施: Administration of drugs concomitantly. (Drug)
结局指标
主要结局
Success rate of complete abortion
时间窗: two weeks
Success rate of complete abortion without any other surgical intervention
次要结局
- Bleeding amount(two weeks)
- Self reported pain intensity after two weeks(two weeks)
- patient's satisfaction(two weeks)