Birth Preparedness and Complication ReadinessNCT07666945
The Effects Of Prenatal Health Education On Birth Preparedness And Complication Readiness Among Pregnant Women
A study testing health education intervention on birth preparedness and complication readiness in people with Birth Preparedness and Complication Readiness, run by Bule Hora University at 1 site in Ethiopia.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Birth Preparedness and Complication Readiness
- What is being tested?
- health education intervention on birth preparedness and complication readiness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 May 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
Selected Public Health Centers in the West Shewa Zone
Hāgere Hiywet, Oromiya, 119
About this study
Official 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
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.
Read more
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.
Read the 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.
- Being tested
- health education intervention on birth preparedness and complication readiness
- Keywords
- step-wedged, health education, birth preparedness, complication readiness
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health education intervention on birth preparedness and complication readinessOther
both arms eventually will take educational interventions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: health education intervention on birth preparedness and complication readiness |
| pregnant women who will receive routine health care | No intervention | continue routine health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Preparedness and Complication ReadinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bule Hora University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belete Feyera, Bule Hora University
- Investigators
- Belete Feyera Teso, MPH, Principal investigator, Bule Hora University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666945
- Sponsor's protocol ID
- BHU/IOH-ERC/04/001/01
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will publish the findings on reputable journal
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07666945
- Acronym / sponsor ID
- BHU/IOH-ERC/04/001/01
- Keywords
- step-wedged, health education, birth preparedness, complication readiness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Bule Hora UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| pregnant women who will take educational intervention | Experimental | Other: health education intervention on birth preparedness and complication readinessAn 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 |
| pregnant women who will receive routine health care | No intervention | –continue routine health care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health education intervention on birth preparedness and complication readinessboth arms eventually will take educational interventions | Other | pregnant women who will take educational intervention |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. I will publish the findings on reputable journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Belete Feyera Teso, MPH principal investigator
Bule Hora University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education intervention on birth preparedness and complication readiness in people with Birth Preparedness and Complication Readiness, run by Bule Hora University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belete Feyera Olkaba, MPH (+251913694024, beletefeyera@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
birth preparedness and complication readiness (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.