Simplified Medical Abortion in Rural India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 731
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
It is estimated that around 50 000 women die every year due to consequences of unsafe abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place a huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care (CAC) would mean important improvements for the concerned women and their families (Singh, 2006) as well as for the societies at large. Recommended improvements concern increased access to the safest and most cost-effective methods such as medical abortion provided at primary level facilities (Singh et al, 2009). A Cochrane Review concludes that most randomised controlled trials within the field of medical abortion are conducted in high-income settings with good access to emergency health care services (Kulier et al, 2004). A simplified regime for medical abortion, which could be used at primary level facilities, would contribute to the reduction of maternal mortality and morbidity related to unsafe abortions globally. However, there is a knowledge gap in order to determine if a simplified follow up of medical abortion is equally effective as the standard procedure in a low-income setting. The results will provide evidence-based information to be used in revising training and service delivery guidelines' in order to reduce maternal mortality and morbidity in both low and high-income setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •women presenting with a positive urine test and uterine size equivalent to or up to 9 +0 weeks (63 days) of gestation
- •opting for medical abortion and
- •residing in an area where follow-up is feasible.
- •woman agrees for a follow up contact at 10-14 days.
排除标准
- •women with contraindications to medical abortions,
- •haemoglobin level less than 85 (Hb < 85) and
- •age less than 18 years.
结局指标
主要结局
Efficacy
时间窗: At 10-14 days follow up
efficacy of self-assessment, measured as the rate of complete abortion, relative to routine follow up . The percentage of women requiring surgical intervention, extra visits and administration of additional misoprostol will be used to monitor incomplete abortion.
次要结局
- Safety(Up to 10-14 days Follow Up)
研究者
Kristina Gemzell Danielsson
Professor
Karolinska Institutet
