Phase Study Comparing Between Expectant Management and Misoprostol Treatment for Intra-uterine Residua After Pregnancy Termination, Abortion or Delivery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- abscence of sonographic finding in the uterine cavity
研究概览
简要总结
The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better.
详细描述
Retained products of conception are estimated to occur after approximately 1-6% of pregnancies, probably more often after termination of early pregnancies then after term pregnancy. Complication are abdominal pain, infection, bleeding and for the long term - intrauterine adhesions.Blood clots in the uterine cavity can cause similar complications. The definitive treatment is curettage or hysteroscopy, both of which are carried out under general anesthesia and require an operating theater. Although expectant management and uterotonic drugs are practically used in such situation, they are not described in the literature.This study compare between the outcome of misoprostol treatment and expectant management in the case of intrauterine residua after completion of pregnancy.
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 with sonographic examination reveals suspicion of intra-uterine residua after completion of pregnancy
- •intrauterine cavity, including endometrium, will be at least 15mm
排除标准
- •the need for emergency surgical treatment (curettage)
- •fever - at least 38 celsius degree
- •women who had medical termination of pregnancy and the examination is after less then 2 weeks since treatment
研究组 & 干预措施
Intra-uterine residua. misoprostol
The patients in this arm will be treated with misoprostol at the recruitment day. If there will be sonographic evidence of intra-uterine residua the day after, they'll gat another dose.
干预措施: misoprostol (Drug)
结局指标
主要结局
abscence of sonographic finding in the uterine cavity
时间窗: one week since recruitment
ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width \> 15mm
次要结局
- Complications(Within one week since recruitment)
- Woman's satisfaction(One week since recruitment)