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The Effects Of Prenatal Health Education On Birth Preparedness And Complication Readiness Among Pregnant Women

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07666945
Enrollment
576
Registered
2026-06-24
Start date
2026-05-01
Completion date
2026-10-30
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Preparedness and Complication Readiness

Keywords

step-wedged, health education, birth preparedness, complication readiness

Brief summary

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.

Detailed description

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.

Interventions

OTHERhealth education intervention on birth preparedness and complication readiness

both arms eventually will take educational interventions

Sponsors

Bule Hora University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

random allocator

Intervention model description

Stepped wedge designs incorporate data collection at each point where a new cluster of pregnant women receives the intervention and assess study variables like sociodemographic characteristics, knowledge, attitude, and use of health services regarding obstetric danger signs and birth preparedness and complication readiness

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
birth preparedness and complication readiness6monthsIf a woman reported that she willprearranges at least two of the five components of birth preparedness and complicationreadiness (willl be assessed by standard pretestedquestionnaires), she will be considered "well prepared forbirth."; But if a pregnant woman reports that she prearranges fewer than two components of birth preparedness and complication readiness, she will be considered "poorly prepared." These five components of birth preparedness and complication readiness are: * Identification of the place of delivery, * saving money, * arranging transport, * identifying a birth companion, and * prearranging a potential blood donor, These are measured by pretested questionnaires.

Countries

Ethiopia

Contacts

CONTACTBelete Feyera Olkaba, MPH
beletefeyera@yahoo.com+251913694024
PRINCIPAL_INVESTIGATORBelete Feyera Teso, MPH

Bule Hora University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026