Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Complete abortion without recourse to surgical intervention.
研究概览
简要总结
In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Uterine size no larger than 12 weeks LMP at time of presentation for care.
- •Past or present history of vaginal bleeding during pregnancy.
- •Open cervical os.
- •If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
- •All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
- •General good health.
- •Willing to provide contact information for purposes of follow-up.
- •Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).
排除标准
- •Contraindications to study drug
- •Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
- •Hemodynamic disturbances (pulse >110/min and systolic bp <100)
- •Have an IUD in place; (the IUD may be removed making the woman eligible)
- •Suspected ectopic pregnancy
研究组 & 干预措施
surgery
standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
干预措施: surgery (Procedure)
misoprostol
400 mcg misoprostol
干预措施: misoprostol (Drug)
结局指标
主要结局
Complete abortion without recourse to surgical intervention.
时间窗: follow up visit 7 days after initial treatment
次要结局
未报告次要终点