An interventional study of Health education in Maternal Death, sponsored by Hawassa University. Recruiting at 1 site in Ethiopia. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Hawassa University · Not applicable, Interventional, and Health services research
Introduction: Maternal health service (MHS) utilization helps to decrease maternal morbidity and mortality. However, the existing evidence is not sufficient to design effective and efficient strategies.
Objective: This study aims to improve maternal health service utilization among women of reproductive age in the Dale and Wonsho districts of the Sidama region, Ethiopia.
Methods: A community-based cross-sectional study will be carried out to assess the utilization and predictors of maternal health care. A phenomenological qualitative study will be conducted to explore perceptions, barriers, and facilitators of maternal health care. A cluster randomized controlled trial will be employed to assess the effect of health education on maternal knowledge about obstetric danger signs, birth preparedness and complication readiness plan, and maternal health service utilization (MHSU). The minimum required sample size is 1,104 for a cross-sectional study. To explore perceptions, barriers, and facilitators of maternal health care a minimum of 20 in-depth interviews, 3 focus group discussions per group, and 20 key informative interviews will be conducted. The minimum required sample size to assess the effect of health education on outcomes is 942. Data will be entered into Epi Data version 3.1 and exported to the SPSS and Stata software for analysis. Descriptive analyses will be carried out to get descriptive measures for the important variables of interest. The generalized estimated equations analysis will be used to assess the potential predictors of MHSU. The coding and analysis of the qualitative data will be done using the thematic content analysis technique by Atlas-Ti software and presented in narratives.
Schedule and budget: This study will be conducted from October to August 2023; the total cost of the project will be 421,600 ETB (7,026.67 EURO).
Introduction: Maternal health service (MHS) utilization helps to decrease maternal morbidity and mortality. However, the utilization of MHS is low in Ethiopia compared to the national target and is a complex phenomenon affected by several predictors. Its predictors, barriers, and facilitators differ from region to region in Ethiopia, and existing evidence is not adequate to design effective and efficient intervention strategies. One of the methods to increase the utilization of maternal health care is improving maternal knowledge about obstetric danger signs, skills of birth preparedness, and complication readiness practice using health education. However, the effect of health education on these outcomes had not been comprehensively explored and the presently existing studies reported controversial results.
Objective: This study aims to improve maternal health service utilization among women of reproductive age in the North Zone of the Sidama region, Ethiopia.
Methods: A community-based cross-sectional study will be carried out to assess the utilization and predictors of maternal health care. A phenomenological qualitative study will be conducted to explore perceptions, barriers, and facilitators of maternal health care. A cluster randomized controlled trial will be employed to assess the effect of health education on maternal knowledge about obstetric danger signs, birth preparedness and complication readiness plan, and maternal health service utilization. The minimum required sample size is 1,104 for a cross-sectional study. To explore perceptions, barriers, and facilitators of maternal health care a minimum of 20 in-depth interviews, 3 focus group discussions per group, and 20 key informative interviews will be conducted. The minimum required sample size is 942 for the interventional study. A multi-stage sampling method will be used to select the study participants for a cross-sectional study. A maximum variance sampling method will be used for the qualitative study. A cluster-randomized sampling method will be utilized for the interventional study. Quantitative data will be collected using a validated, pre-tested, and structured questionnaire. Qualitative data will be collected using pre-tested focus group discussions, in-depth interviews, and key informant interview guides until information saturation is reached. The intervention group will be received 12 rounds of pre-recorded audio-based health education. The utilization of maternal health care will be measured at baseline and 6 months after the intervention. Data will be entered into Epi Data version 3.1 and exported to the SPSS and Stata software for analysis. Descriptive analyses will be carried out to get descriptive measures for the important variables of interest. The generalized estimated equations (GEE) analysis will be used to assess the potential predictors of MHSU. The coding and analysis of the qualitative data will be done using the thematic content analysis technique by Atlas-Ti software and presented in narratives. For maternal knowledge about the danger signs and practice of birth preparedness and complication readiness, the multilevel linear regression models will be utilized. The generalized mixed models or GEE will be utilized to adjust for between and within-cluster variation for MHSU. The intention-to-treat analysis will be used to compare outcomes between groups. The independent t-tests will be used to compare the effect of the intervention between the two groups. The statistical significance level will be adjusted to account for the effect of multiple comparison problems using the Bonferroni corrections methods.
Schedule and budget: This study will be conducted from December 2022 to December 2023; the total cost of the project will be 421,600 ETB (7,026.67 EURO) and funded by Hawassa University and the Sidama Regional State Administration.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 1,126 is close to the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →Hawassa University is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention group: will receive routine plus pre-recorded audio-based HEI package for six months until date of delivery.
Behavioral: Health education
Comparator group: will receive the routine health education package for six months until the date of delivery as per the Ethiopian guidelines.
Behavioral: Health education
Health education will be delivered for six months, two times per month; one session will take one hour, and an overall 12 sessions will be conducted. One health education session consists of key messages on normal pregnancy and childbirths, ODS during pregnancy, delivery, and the postpartum period, the practice of BPCR, and the benefits of MHSU. The other actions executed by WDT facilitators will be the motivating mother and their families to utilize MHS. One hour will be allocated for each session, from this 20 minutes will be allowed for the pre-recorded an audio-based lecturer and the remaining 40 minutes will be allowed for raising questions and responses (discussion). After the session, some of the women will be selected to carry out role play which is basic to demonstrate the important messages and share experiences.
To evaluate the effect of health education intervention on maternal health service utilization among women of reproductive age in North Zone of the Sidama region, Ethiopia.
After the end of intervention period the maternal health service utilization will be measure using the yes and no responses by women's self report
Time frame: 6 months
To assess the effect of health education intervention on the knowledge of mothers regarding obstetric danger signs and birth preparedness and complication reediness practice among women of reproductive age in North Zone of the Sidama region, Ethiopia.
After the end of intervention period the obstetric danger signs and birth preparedness and complication readiness will be measure using the yes and no responses by women's self report
Time frame: 6 months
Plan to share: Yes — The findings of the study will be published in peer-reviewed international journals and discussed at national and international seminars and scientific conferences. Also, the findings will be officially presented to the Hawassa University School of Public Health. The summary of the main findings will be delivered to the district health office and the Sidama region health bureau. The findings will also be distributed to vital stakeholders in maternal health policy, comprising the WHO.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 09/08/2024
Access criteria: un on request from primary author
Started Jan 2023 (actual). Primary completion is estimated for Aug 2023, 7 months after the start.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hawassa University