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临床试验/NCT05015023
NCT05015023招募中不适用

Effectiveness of Health Education Provided to Couples on Knowledge, Attitude, and Utilization of Maternity Waiting Homes in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial

Jimma University2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
320
试验地点
2
主要终点
Utilization of MWH

研究概览

简要总结

Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal & neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. It is important to investigate what strategies could be effective in improving MWH utilization. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of male partner involvement intervention on MWH utilization in Ethiopia.

详细描述

The primary cause of adverse maternal health outcomes has been identified to be the delay in reaching care. This is often attributed to the long distances women need to travel to gain access to health facilities. Literature shows that maternity waiting homes contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal and neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. So, it is important to investigate what strategies could be effective in improving MWH utilization in Ethiopia.

The aim of this study is to evaluate the effect of male partner involvement intervention on MWH utilization in Hadiya Zone, Southern Ethiopia. A cluster-randomized controlled trial will be performed. The intervention will have two arms, i.e., intervention and control. It will be a behavioral intervention. The interventions will be health education, home visit, and the provision of Information Education Communication (IEC) materials/leaflets. Health education will be delivered to "husband-expectant wife" pairs at the baseline. Then home visits will be conducted two times (in the third and fifth months of the intervention period). Leaflets will be provided to the study participants three times, i.e., at the baseline and during every home visit. The study participants will be pregnant women at the beginning of their second trimester living with their male partners at the time of the study.

Randomization will be conducted at the cluster level. Clusters will be Kebeles'. There will be 16 clusters or Kebeles. Data collectors (assessors) will be masked. The trial sample size will be 320 [160 in each arm]. A Generalized Estimating Equations model will be used. Data analysis will be conducted by SPSS or STATA software (as appropriate) using an Intention-To-Treat Approach. The duration of the intervention will be six months.

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

The outcome assessors will be masked.

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women at the beginning of second trimesters (14-16 weeks of gestation)
  • Pregnant women currently live with their male partners
  • Pregnant women permanent residents of the study area
  • Pregnant women live in a place ≥2 hours of walking distance from the nearest health facility and/or have no access to public transportation
  • Pregnant women whose husbands/male partners will be willing to participate in the study

排除标准

  • Pregnant women ≤ 13 weeks of gestation
  • Pregnant women not living with their male partners at the time of the study
  • Pregnant women who are not permanent residents of the study area
  • Pregnant women live in a place < 2 hours of walking distance from the nearest health facility or have access to transportation
  • Pregnant women whose husbands are not willing to participate in the study.

结局指标

主要结局

Utilization of MWH

时间窗: up to six months

Utilization of MWH is the use of MWHs by pregnant women in their final weeks of pregnancy to bridge the geographic gap in obstetric care. It is the proportion of pregnant women who use MWHs in the final weeks of pregnancy among the eligible women who are study participants.

次要结局

  • Level of Maternal Knowledge and Attitude(up to six months)

研究者

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

Teklemariam Yarinbab, MPH

Assistant Professor

Jimma University

研究点 (2)

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