Simplified Medical Abortion in Rural India
2014年8月13日 更新者:Kristina Gemzell Danielsson、Karolinska Institutet
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.
研究概览
研究类型
介入性
注册 (实际的)
731
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Rajasthan
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Udaipur、Rajasthan、印度、313001
- ARTH
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- women with contraindications to medical abortions,
- haemoglobin level less than 85 (Hb < 85) and
- age less than 18 years.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:Duo test
Self assessment
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Intervention group: Simplified followup Mifepristone at outpatient clinic, followed by the administration of misoprostol 24-48 hours later (in the clinic or at home).
The women will not return to the clinic for routine follow up visit, but are given instructions on how to use a checklist and a low sensitivity pregnancy test around day 10-14.
They are asked only to return if they have any health problems or screen positively.
The low sensitivity urinary-hCG (with HCG of 1000 IU/ml) test will be used.
Women will be provided the pregnancy test free of cost along with a pictorial checklist.
A research assistant or a nurse will explain in detail how to use the pregnancy test as well as the checklist, and provide phone numbers in case of any questions or doubts.
Follow-up interviews will be conducted through home visits or phone (if woman has one) during the next 1-2 days to screen for on-going pregnancies and assess acceptability the self-assessment.
其他名称:
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其他:Routine follow up
Follow up in the clinic
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Follow up in the clinic
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Efficacy
大体时间: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.
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At 10-14 days follow up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety
大体时间:Up to 10-14 days Follow Up
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unscheduled visits for various adverse events/complications, side effects of medical abortion including infections, bleeding, pain
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Up to 10-14 days Follow Up
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
contraceptive uptake
大体时间:at approx. 2 weeks after abortion (at FU)
|
Number of women who have started a contraceptive method or is planning to start a method
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at approx. 2 weeks after abortion (at FU)
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time consumption
大体时间:at 10-14 days Follow Up
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Time spent for clinical visits/contacts
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at 10-14 days Follow Up
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Acceptability
大体时间:at 10-14 days follow up
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Acceptability (evaluated by a questionnaire)of home self assessment of complete pregnancy using a low sensitivity u-hCG test
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at 10-14 days follow up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Sharad Iyengar, MD、ARTH
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Paul M, Iyengar SD, Essen B, Gemzell-Danielsson K, Iyengar K, Bring J, Klingberg-Allvin M. Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial. BMC Public Health. 2016 Oct 17;16(1):1087. doi: 10.1186/s12889-016-3726-1.
- Paul M, Iyengar K, Essen B, Gemzell-Danielsson K, Iyengar SD, Bring J, Soni S, Klingberg-Allvin M. Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Sep 1;10(9):e0133354. doi: 10.1371/journal.pone.0133354. eCollection 2015.
- Iyengar K, Paul M, Iyengar SD, Klingberg-Allvin M, Essen B, Bring J, Soni S, Gemzell-Danielsson K. Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial. Lancet Glob Health. 2015 Sep;3(9):e537-45. doi: 10.1016/S2214-109X(15)00150-3.
- Paul M, Iyengar K, Iyengar S, Gemzell-Danielsson K, Essen B, Klingberg-Allvin M. Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India--study protocol and intervention adaptation of a randomised control trial. BMC Womens Health. 2014 Aug 15;14:98. doi: 10.1186/1472-6874-14-98.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2013年4月3日
首先提交符合 QC 标准的
2013年4月5日
首次发布 (估计)
2013年4月10日
研究记录更新
最后更新发布 (估计)
2014年8月15日
上次提交的符合 QC 标准的更新
2014年8月13日
最后验证
2014年8月1日
更多信息
与本研究相关的术语
其他研究编号
- WDuo2013
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