Maternal DeathNCT05015023
Effectiveness of Health Education Provided to Couples on Utilization of Maternity Waiting Homes in Rural Ethiopia
A study testing Behavioral intervention in people with Maternal Death and Maternal Behavior, run by Jimma University at 1 site in Ethiopia.
Trial summary
Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Death, Maternal Behavior
- What is being tested?
- Behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Nov 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women at the beginning of second trimesters (14-16 weeks of gestation)
- Pregnant women currently live with their male partners
- Pregnant women permanent residents of the study area
- Pregnant women live in a place ≥2 hours of walking distance from the nearest health facility and/or have no access to public transportation
- Pregnant women whose husbands/male partners will be willing to participate in the study
Who cannot join
- Pregnant women ≤ 13 weeks of gestation
- Pregnant women not living with their male partners at the time of the study
- Pregnant women who are not permanent residents of the study area
- Pregnant women live in a place < 2 hours of walking distance from the nearest health facility or have access to transportation
- Pregnant women whose husbands are not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Jimma University
Jimma, Oromiya, 378
Teklemariam Yarinbab, MPH, +251930504891, teklemariam36@gmail.com
About this study
Official title: Effectiveness of Health Education Provided to Couples on Knowledge, Attitude, and Utilization of Maternity Waiting Homes in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial
Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal \& neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. It is important to investigate what strategies could be effective in improving MWH utilization. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of male partner involvement intervention on MWH utilization in Ethiopia.
Read the detailed description
The primary cause of adverse maternal health outcomes has been identified to be the delay in reaching care. This is often attributed to the long distances women need to travel to gain access to health facilities. Literature shows that maternity waiting homes contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal and neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. So, it is important to investigate what strategies could be effective in improving MWH utilization in Ethiopia.
The aim of this study is to evaluate the effect of male partner involvement intervention on MWH utilization in Hadiya Zone, Southern Ethiopia. A cluster-randomized controlled trial will be performed. The intervention will have two arms, i.e., intervention and control. It will be a behavioral intervention. The interventions will be health education, home visit, and the provision of Information Education Communication (IEC) materials/leaflets. Health education will be delivered to "husband-expectant wife" pairs at the baseline. Then home visits will be conducted two times (in the third and fifth months of the intervention period). Leaflets will be provided to the study participants three times, i.e., at the baseline and during every home visit. The study participants will be pregnant women at the beginning of their second trimester living with their male partners at the time of the study.
Randomization will be conducted at the cluster level. Clusters will be Kebeles'. There will be 16 clusters or Kebeles. Data collectors (assessors) will be masked. The trial sample size will be 320 [160 in each arm]. A Generalized Estimating Equations model will be used. Data analysis will be conducted by SPSS or STATA software (as appropriate) using an Intention-To-Treat Approach. The duration of the intervention will be six months.
- Conditions
- Maternal Death, Maternal Behavior
- Being tested
- Behavioral intervention
- Keywords
- maternity waiting home, male partner, Ethiopia
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral interventionBehavioural
A cluster-randomized controlled trial will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The behavioral intervention will be conducted on the experimental group for consecutive six months. The components of the intervention will be group health education, provision of IEC materials/Leaflets, and home visits. Receives: Behavioral: Behavioral intervention |
| Control | No intervention | The routine care will be continued in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of MWH
Utilization of MWH is the use of MWHs by pregnant women in their final weeks of pregnancy to bridge the geographic gap in obstetric care. It is the proportion of pregnant women who use MWHs in the final weeks of pregnancy among the eligible women who are study participants.
Measured: up to six months
Secondary outcomes (1)
Level of Maternal Knowledge and Attitude
Knowledge will be measured using 'Yes' or 'No' questions and attitude will be measured using the Likert scale. There will be 7 questions for the knowledge assessment and 5 questions with 5 points Likert scales for the attitude assessment. Individual scores on each item will be added to yield the sum score. Participants who score above the median in the assessment will be regarded to be knowledgeable or have a good attitude about MWHs, while those who score below the median will be judged to have poor knowledge or an unfavorable attitude.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Nov 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal DeathStudies 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
- Parallel groups
- Model description
- The study will have two arms, i.e., intervention and control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teklemariam Yarinbab, MPH, Jimma University
- Investigators
- Teklemariam E Yarinbab, MPH, Principal investigator, Mizan Tepi UniversityHailay A Gesesew, PhD, Principal investigator, Torrens University AustraliaTefera Belachew, PhD, Principal investigator, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015023
- Sponsor's protocol ID
- RP0901/11
- Status last verified
- Feb 2023
- First submitted
- 3 Aug 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Publications
Yarinbab TE, Gesesew HA, Belachew T. Effect of health education provided to couples on maternal knowledge, attitude and use of maternity waiting homes in rural Ethiopia: A cluster-randomized trial. Midwifery. 2024 Nov;138:104153. doi: 10.1016/j.midw.2024.104153. Epub 2024 Aug 22.
PubMed 39197275Yarinbab TE, Gesesew HA, Harrison MS, Belachew T. Effect of couple-based health education on male-partners knowledge and attitude towards maternity waiting homes in rural Ethiopia: a cluster-randomized trial. Sci Rep. 2023 Oct 27;13(1):18446. doi: 10.1038/s41598-023-45681-4.
PubMed 37891206
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Education Provided to Couples on Knowledge, Attitude, and Utilization of Maternity Waiting Homes in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05015023
- Acronym / sponsor ID
- RP0901/11
- Conditions
- Maternal Death, Maternal Behavior
- Keywords
- maternity waiting home, male partner, Ethiopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Aug 2021 (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.
Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal \& neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. It is important to investigate what strategies could be effective in improving MWH utilization. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of male partner involvement intervention on MWH utilization in Ethiopia.
Detailed description
The primary cause of adverse maternal health outcomes has been identified to be the delay in reaching care. This is often attributed to the long distances women need to travel to gain access to health facilities. Literature shows that maternity waiting homes contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal and neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. So, it is important to investigate what strategies could be effective in improving MWH utilization in Ethiopia.
The aim of this study is to evaluate the effect of male partner involvement intervention on MWH utilization in Hadiya Zone, Southern Ethiopia. A cluster-randomized controlled trial will be performed. The intervention will have two arms, i.e., intervention and control. It will be a behavioral intervention. The interventions will be health education, home visit, and the provision of Information Education Communication (IEC) materials/leaflets. Health education will be delivered to "husband-expectant wife" pairs at the baseline. Then home visits will be conducted two times (in the third and fifth months of the intervention period). Leaflets will be provided to the study participants three times, i.e., at the baseline and during every home visit. The study participants will be pregnant women at the beginning of their second trimester living with their male partners at the time of the study.
Randomization will be conducted at the cluster level. Clusters will be Kebeles'. There will be 16 clusters or Kebeles. Data collectors (assessors) will be masked. The trial sample size will be 320 [160 in each arm]. A Generalized Estimating Equations model will be used. Data analysis will be conducted by SPSS or STATA software (as appropriate) using an Intention-To-Treat Approach. The duration of the intervention will be six months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will have two arms, i.e., intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behavioral interventionThe behavioral intervention will be conducted on the experimental group for consecutive six months. The components of the intervention will be group health education, provision of IEC materials/Leaflets, and home visits. |
| Control | No intervention | –The routine care will be continued in the control group. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women at the beginning of second trimesters (14-16 weeks of gestation)
- Pregnant women currently live with their male partners
- Pregnant women permanent residents of the study area
- Pregnant women live in a place ≥2 hours of walking distance from the nearest health facility and/or have no access to public transportation
- Pregnant women whose husbands/male partners will be willing to participate in the study
Key exclusion criteria (5 listed)
- Pregnant women ≤ 13 weeks of gestation
- Pregnant women not living with their male partners at the time of the study
- Pregnant women who are not permanent residents of the study area
- Pregnant women live in a place < 2 hours of walking distance from the nearest health facility or have access to transportation
- Pregnant women whose husbands are not willing to participate in the study.
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 |
|---|---|---|
| Behavioral interventionA cluster-randomized controlled trial will be conducted. | Behavioural | Intervention |
Primary outcome
Utilization of MWH
Time frame: up to six months
Utilization of MWH is the use of MWHs by pregnant women in their final weeks of pregnancy to bridge the geographic gap in obstetric care. It is the proportion of pregnant women who use MWHs in the final weeks of pregnancy among the eligible women who are study participants.
1 secondary outcome
Level of Maternal Knowledge and Attitude
Time frame: up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 39197275Yarinbab TE, Gesesew HA, Belachew T. Effect of health education provided to couples on maternal knowledge, attitude and use of maternity waiting homes in rural Ethiopia: A cluster-randomized trial. Midwifery. 2024 Nov;138:104153. doi: 10.1016/j.midw.2024.104153. Epub 2024 Aug 22.
- Derived from this study: PubMed 37891206Yarinbab TE, Gesesew HA, Harrison MS, Belachew T. Effect of couple-based health education on male-partners knowledge and attitude towards maternity waiting homes in rural Ethiopia: a cluster-randomized trial. Sci Rep. 2023 Oct 27;13(1):18446. doi: 10.1038/s41598-023-45681-4.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
Related trials for Maternal Death
Enrolling by invitation
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The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
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Scaling up Maternal Health Equity Best Practices
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Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
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Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
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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. This study is not recruiting at the moment.
Teklemariam E Yarinbab, MPH principal investigator
Mizan Tepi University
Hailay A Gesesew, PhD principal investigator
Torrens University Australia
Tefera Belachew, PhD principal investigator
Jimma 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 Behavioral intervention in people with Maternal Death and Maternal Behavior, run by Jimma 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teklemariam E Yarinbab, MPH (+251930504891, teklemariam36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of MWH (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05015023, which also lists 2 linked publications.
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 8 Feb 2023.