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NCT Number: NCT07666945

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selected Public Health Centers in the West Shewa Zone

Hāgere Hiywet, Oromiya, 119, Ethiopia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

health education intervention on birth preparedness and complication readiness

Other

both arms eventually will take educational interventions

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Belete Feyera Olkaba, MPH

CONTACT

[email protected]

+251913694024

Sponsors and collaborators

Lead sponsor

Bule Hora University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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