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

June 19, 2026 updated by: Belete Feyera, Bule Hora University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

576

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ethiopia
    • Oromiya
      • Hāgere Hiywet, Oromiya, Ethiopia, 119
        • Recruiting
        • Selected Public Health Centers in the West Shewa Zone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pregnant women who will take educational intervention
An intervention is rolled out sequentially to the trial participants' clusters of individuals over a number of time periods. The order in which the different clusters of pregnant women receive the intervention is determined at random, and, by the end of the random allocation, all clusters of pregnant women will have received the intervention. Stepped wedge designs incorporate data collection at each point where a new cluster of pregnant women receives the intervention. Each participant will be assigned an identity number throughout the recruitment process. To remind each participant of the date of the intervention and/or follow-up interview, their phone numbers will be recorded. Leaflets will be distributed at each of the contact points as teaching aids. The health education content or the module will be adopted from JHPIEGO and the Ethio Ministry of Health ANC education guidelines. The adopted module will be evaluated by experts in the area of reproductive health
Other: health education intervention on birth preparedness and complication readiness
both arms eventually will take educational interventions
No Intervention: pregnant women who will receive routine health care
continue routine health care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
birth preparedness and complication readiness
Time Frame: 6months

If 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.
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bule Hora University

Investigators

  • Principal Investigator: Belete Feyera Teso, MPH, Bule Hora University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHU/IOH-ERC/04/001/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I will publish the findings on reputable journal

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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