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临床试验/NCT01844024
NCT01844024已完成4 期

Task Sharing to Improve Post Abortion Care at District Health Care Level- Trial in Uganda

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 1,010 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
1,010
试验地点
1
主要终点
Complete abortion

研究概览

简要总结

Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women's access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care 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
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •bleeding and contractions during pregnancy

排除标准

  • •women with known allergy to misoprostol,
  • •a uterine size more than 12 weeks of gestation,
  • •suspected ectopic pregnancy,
  • •unstable hemodynamic status and chock,
  • •signs of pelvic infection and/or sepsis.

研究组 & 干预措施

misoprostol by midwife

Other

Women with incomplete abortion is diagnosed and treated with misoprostol by midwife

干预措施: misoprostol by midwife (Other)

Misoprostol by physician

No Intervention

Women with incomplete abortion is diagnosed and treated with misoprostol by physician

结局指标

主要结局

Complete abortion

时间窗: 14 days

The clinical assessments of the main outcome are: (i) Physical examination (pulse, blood pressure and temperature); (ii) Pelvic examination that includes examination of size of the uterus (external genitalia, speculum examination, bimanual examination).

次要结局

  • bleeding(14 days)
  • pain(14 days)
  • acceptability(14 days)
  • un-scheduled visits(14 days)

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 (1)

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