An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia
研究概览
详细说明
A three-arm cluster trial design will be used to measure the impact of the intervention packages in three districts (Gomma, Seka Chekorsa, Kersa) in Jimma Zone, Ethiopia. Twenty-four clusters with 160 individuals each are required to detect a 17% change in the primary outcome (proportion of facility-based births) with 80% power,assuming a cluster autocorrelation of 0.8 and an intra-cluster correlation coefficient of 0.1. Primary health care units (PHCU) which consist of a health centre and several community-based health posts will serve as trial clusters. All PHCUs with maternity waiting areas (MWAs) constructed will be eligible for selection. Eligible women will be randomly selected from PHCU catchment areas stratified by MWA functionality and health centre basic emergency obstetric care (BEmOC) capacity. This is to ensure balanced distribution of poorly functioning MWAs and facilities with diminished BEmOC capacity between trial arms.
Cross-sectional household surveys will be conducted with eligible women to collect information on socio-demographics, knowledge, attitudes and practices regarding maternal health services, reproductive history and maternal health service utilization. Surveys will be administered by trained interviewers on tablet computers programmed using Open Data Kit at baseline prior to intervention roll out and at endline. Multilevel regression models will be used to quantify the effect of the intervention packages on outcomes of interest. Random effect terms for PHCUs will be included to account for the clustered nature of the data.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women who were pregnant up to one year prior to the baseline survey and had a live birth, stillbirth or abortion (spontaneous or induced) and are residents in the study districts during the survey period are eligible to take part in the study.
Exclusion Criteria:
- Women who are not able to provide informed consent due to severe illness or mental health conditions.
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
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实验性的：MWA+IEC intervention
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The MWA intervention will involve upgrading existing maternity waiting areas to ensure that essential supplies and services are available to create a comfortable environment for women to temporarily reside in and have easy access to skilled obstetric services.
Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences. Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities. Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences. |
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实验性的：IEC intervention
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Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences. Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities. Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences. |
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 |
|---|---|---|
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Facility-based birth coverage
大体时间：Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
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Proportion of women who report giving birth to their last child at a health facility (health centre or hospital) which has skilled birth attendants present (doctor, midwife, clinical nurse).
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Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
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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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Antenatal care coverage
大体时间：Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
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Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
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Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
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Postnatal care coverage
大体时间：Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
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Proportion of women who report receiving a checkup from a healthcare worker at least once during the 42 days after delivery of their last child.
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Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
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合作者和调查者
调查人员
- 首席研究员：Manisha Kulkarni, PhD、University of Ottawa
- 首席研究员：Lakew Abebe, MPH、Jimma University
出版物和有用的链接
一般刊物
- Kurji J, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Bergen N, Kiros G, Asefa Y, Asfaw S, Mamo A, Endale E, Thavorn K, Labonte R, Taljaard M, Kulkarni MA. Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia. BMC Public Health. 2020 Oct 22;20(1):1593. doi: 10.1186/s12889-020-09692-4.
- Kurji J, Kulkarni MA, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Thavorn K, Labonte R, Taljaard M. Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial. Trials. 2019 Dec 4;20(1):671. doi: 10.1186/s13063-019-3755-z.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 108028-002
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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MWA intervention的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘