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临床试验/NCT00674232
NCT00674232已完成不适用

Misoprostol for Treatment of Incomplete Abortion

Gynuity Health Projects3 个研究点 分布在 2 个国家目标入组 311 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
311
试验地点
3
主要终点
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason

研究概览

简要总结

This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

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
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • past or present history of vaginal bleeding during pregnancy
  • open cervical os
  • evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
  • surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
  • generally in good health
  • woman lives or works within one hour of study site
  • woman willing to provide contact information for follow up purposes
  • informed consent given

排除标准

  • contraindications to study drug
  • uterine size larger than 12 weeks LMP
  • signs of severe infection

研究组 & 干预措施

Misoprostol

Experimental

Group 1 randomized to take single dose of 600 mcg oral misoprostol

干预措施: 600 mcg misoprostol (Drug)

Surgical treatment

Other

Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)

干预措施: Surgical treatment (Procedure)

结局指标

主要结局

complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason

时间窗: one week after initial treatment

次要结局

  • side effects(measured at follow up visit one week after initial treatment)
  • acceptability(measured at follow up visit one week after initial treatment)

研究者

发起方
Gynuity Health Projects
申办方类型
Other

研究点 (3)

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