Effectiveness of an Integrated Community-based Intervention Package in Improving Maternal, and Neonatal Health Outcome in Jimma Zone, Southwest Ethiopia: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Neonatal care practices
研究概览
简要总结
This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.
详细描述
Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in low and middle-income countries. Community-based Interventions and strategies for improving maternal, newborn, and child health care have been recommended through a continuum of care approach. However, few efforts have been made to identify synergies and integrate different intervention packages across the country.
Objective
This study aims to assess the effectiveness of an integrated community-based intervention package in improving maternal, neonatal and infant health outcomes in Jimma Zone, Southwest Ethiopia: a cluster randomized controlled trial.
Methods: This is a parallel-arm, single-blind, cluster randomized controlled trial conducted in the Dedo and Seka Chekorsa districts of the Jimma zone. After excluding 10 kebeles from each district to be considered as a buffer zone, we will assign 26 kebeles to the intervention arm and 26 to the control arm. A total of 624 pregnant women in their third trimester who reside in the kebeles assigned to the intervention clusters will be identified and enrolled (312 in intervention and 312 in control groups). The intervention includes Behavioral Change Communication, and male involvement. Various multidisciplinary professionals and experts regularly monitor the overall process of the research and intervention activities. The effect of the intervention in comparison with the routine care will be assessed by fitting mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes. In all analyses, adjustment will be made for clustering at the kebele level and covariate. All tests will be two-sided and the level of significance will be set at alpha < 0.05.
Budget: A total of 579,888.4ETB will be required. Key words: community-based intervention, maternal, neonatal, infant, health outcome, randomized controlled trial
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
- Single (Outcomes Assessor)
盲法说明
Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation.
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in the third trimester
- •Live in the selected cluster
排除标准
- •Serious illness or clinical complications requiring hospitalization
- •Maternal death
- •Newborn death
- •Stillbirth
- •Twin gestation
- •Preterm birth (at <37 weeks)
研究组 & 干预措施
Intervention group
An integrated Community-based package of interventions An integrated intervention consisting of behaviourchange communication, and male involvement will be delivered to pregnant women in their third trimester. They will receive 2 prenatal and five home visits. each visit will last 40-60 minutes. After delivery mother-newborn pairs will be followed up until six weeks.
干预措施: Behaviour Change Communication and Male involvement intervention (Behavioral)
Control group
First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters. Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation.
结局指标
主要结局
Neonatal care practices
时间窗: At month one after delivery
Prevalence of neonatal care practices
Feeding practice
时间窗: At month one after delivery
prevalence of early initiation and exclusive breastfeeding
次要结局
- Neonatal morbidity(At month one after delivery)
- Maternal morbidity(At month one after delivery)
- Birth preparedness and complication readiness plan(At month one after delivery)
- Maternal feeding practice(: At month one after delivery)
- Skilled delivery(At month one after delivery)
研究者
Bekelu Teka Worku
Lecturer and researcher
Jimma University