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临床试验/NCT01827995
NCT01827995已完成4 期

Simplified Medical Abortion in Rural India

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 731 人开始时间: 2013年4月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Gemzell Danielsson

Professor

Karolinska Institutet

研究点 (2)

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