Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,738
- 试验地点
- 8
- 主要终点
- successful menstrual regulation without the need for a surgical evacuation
研究概览
简要总结
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
详细描述
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
The specific aims of this project are as follows:
- Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh;
- Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and
- Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Be willing and able to sign consent forms;
- •Be eligible for menstrual regulation (MR) services according to clinician's assessment;
- •Be willing to undergo a surgical evacuation if necessary;
- •Be willing to provide a urine sample prior to administration of the mifepristone
- •Have ready and easy access to a telephone and
- •Agree to comply with the study procedures and visit schedule
排除标准
- •• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- •Chronic renal failure;
- •Concurrent long-term corticosteroid therapy;
- •History of allergy to mifepristone, misoprostol or other prostaglandin;
- •Hemorrhagic disorders or concurrent anticoagulant therapy;
- •Inherited porphyrias; or
- •Other serious physical or mental health conditions.
研究组 & 干预措施
Mifepristone-misoprostol
Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol
干预措施: Mifepristone and misoprostol (Drug)
结局指标
主要结局
successful menstrual regulation without the need for a surgical evacuation
时间窗: 14 days
次要结局
未报告次要终点