The Effects Of Prenatal Health Education On Birthpreparedness And Complication Readiness Among Pregnant Women In Districts Of West Shewa Zone: A Step-Wedged Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 576
- 试验地点
- 1
研究概览
简要总结
Study setting: The study will be conducted from May 1 to November 2026 in the West Shewa Zone.
Objectives: To measure the effect of health education on birth preparedness and complication readiness practice among pregnant women in the districts of the West Shewa Zone in 2026 (Stepped Wedge Randomized Controlled Trial) Null hypothesis (H₀): There will be no difference in the proportion of birth preparedness and complication readiness among pregnant women between intervention and control periods.
Alternative Hypothesis (Ha): Health education intervention on BPCR will result in a significant increase in the proportion of well-prepared pregnant women in the intervention periods across all study sites.
The study population will consist of randomly selected pregnant women in selected public health centers in Districts of west shewa zone.
The west shewa zone districts were selected by simple random sampling methods .Ejere, Ejersa Lefo and Holota districts were selected using simple random sampling .Then Five health centers namely Yaya , Olankomi, Gorba ,Ejere and Gilgel kuyu health centers from three districts of west shewa zone were selected.
Will be then randomized to time of crossover (step) using computer-generated sequences. Because of this, the study design involves a sequential rollout where all groups eventually receive the health education intervention aimed at evaluating birth preparedness and complication readiness changes. At the beginning, the five clusters were identified by simple random sampling. Sequential allocation or randomly assigning each cluster to a specific wedge or starting point will be conducted. At the baseline all clusters begin in the control phase. During the steps (every month to six months) one or more clusters cross over to the intervention phase (implementing BPCR education). During the end phases, all clusters are in the intervention group. The study involves cohort sampling; the same pregnant women are followed through the entire study for six months. All eligible pregnant women attending antenatal care during defined periods in each cluster will eventually receive health education.
详细描述
Individual participants will serve as the measurement and analysis units, while clusters will serve as the randomization units. Randomization will be done after written informed consent is taken. Clusters will be randomly assigned after confirmation of eligible pregnant women from the clusters. The random allocation will be generated by computer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
random allocator
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who are in the first trimester of their pregnancy (up to 16 weeks' gestation) and
- •Pregnant women who have lived in the study area for more than six months will be included.
排除标准
- •Pregnant women with serious illnesses or those who intend to move during the intervention's execution
- •Severe conditions requiring intensive hospital follow-up.
- •Pregnant women who have previously taken part in a similar study elsewhere will not be allowed to join.
研究者
Belete Feyera
Principal investigator
Bule Hora University