Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Percentage of women who achieved complete evacuation
研究概览
简要总结
Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.
详细描述
Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •missed miscarriages
- •incomplete miscarriages
- •first trimester
排除标准
- •coagulopathy
- •Rhesus negative
- •suspected ectopic pregnancy or pregnancy of unknown location
- •on anticoagulation drug
- •septic miscarriages
- •hemodynamically unstable
研究组 & 干预措施
Gemeprost
Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
干预措施: Gemeprost 1 Mg Vaginal Pessary (Drug)
Gemeprost
Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
干预措施: Dinoprostone 3 mg (Drug)
Dinoprostone
Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
干预措施: Gemeprost 1 Mg Vaginal Pessary (Drug)
Dinoprostone
Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
干预措施: Dinoprostone 3 mg (Drug)
结局指标
主要结局
Percentage of women who achieved complete evacuation
时间窗: from recruitment until up to one week after commencement of treatment
Complete expulsion of product of conception
次要结局
- Percentage of women who experienced side effects(from recruitment until up to one week after commencement of treatment)