Repeated Doses of Misoprostol for Treatment of Missed Abortion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus
排除标准
- •empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
研究组 & 干预措施
repeated doses
patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment.
干预措施: misoprostol (Drug)
结局指标
主要结局
Efficacy
时间窗: 1 day
Complete abortion as judged by ultrasound
次要结局
- Acceptability(1 day, 1 week, 2 weeks, 3 weeks, 5 weeks)
研究者
Kristina Gemzell Danielsson
professor
Karolinska Institutet