Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 720
- 试验地点
- 6
- 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 randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:
In Tanzania and Mozambique:
- 600 mcg of oral misoprostol in one dose, or
- Standard surgical treatment (MVA)
In Moldova and Madagascar:
- 600 mcg of oral misoprostol in one dose, or
- 400 mcg of sublingual misoprostol in one dose.
In Burkina Faso and Vietnam:
- 400 mcg of sublingual misoprostol in one dose.
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
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
- 是
入选标准
- •If no ultrasound used:
- •Past or present history of vaginal bleeding during pregnancy; and
- •Open cervical os.
- •If ultrasound used:
- •Past or present history of vaginal bleeding during pregnancy; and
- •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.
- •Willing to provide contact information for purposes of follow-up.
- •In Tanzania: 18 years of age or over or parental permission
- •In Mozambique: 21 years of age or over or parental permission
- •In Moldova: 18 years of age or over
- •In Madagascar: 18 years of age or parental permission
- •In Vietnam: reproductive age
排除标准
- •Contraindications to the study drug;
- •Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
- •Signs of severe infection, defined as at least one of the following of:
- •foul smelling discharge,
- •fever > 39 degrees C ,
- •pulse >110/min;
研究组 & 干预措施
1
treatment with 600mcg oral misoprostol
干预措施: misoprostol (Drug)
2
treatment with 400mcg sublingual misoprostol
干预措施: misoprostol (Drug)
3
treatment with Manual Vacuum Aspiration (MVA)
干预措施: MVA (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 with the option of an additional week
次要结局
未报告次要终点