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

NCT07666945 | Recruiting DMC

• 1 other identifier: BHU/IOH-ERC/04/001/01
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Preparedness and Complication Readiness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• birth preparedness and complication readiness

  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

Study Arms (2)

pregnant women who will take educational intervention

EXPERIMENTAL

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

pregnant women who will receive routine health care

NO INTERVENTION

continue routine health care

Interventions

health education intervention on birth preparedness and complication readiness OTHER

both arms eventually will take educational interventions

pregnant women who will take educational intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bule Hora University: lead

Study Sites (1)

Selected Public Health Centers in the West Shewa Zone

Hāgere Hiywet, Oromiya, 119, Ethiopia

RECRUITING

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Belete Feyera Teso, MPH

  Bule Hora University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belete Feyera Olkaba, MPH

CONTACT

+251913694024; beletefeyera@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: random allocator
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months

Locations

ET (1)