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Maternal DeathMHSUNCT05865873

Maternal Health Service Utilization Among Women of Reproductive Age in Sidama Region, Ethiopia

A study testing Health education in people with Maternal Death, run by Hawassa University at 1 site in Ethiopia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Death
What is being tested?
Health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,126 participants
Where
1 siteEthiopia
Study dates
1 Jan 2023to 30 Sep 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 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • All pregnant mothers residing in the selected kebeles for at least for 6 months.
  • Must haven't planned to change residence during the implementation of an intervention
  • No psychiatric problems
  • Capable of providing written informed consent
  • Voluntary to be visited by WDT facilitators, data collectors, and supervisors. Exclusion Criteria
  • Women who have a severe illness during the data collection period.
  • Women who experienced stillbirth and infant deaths.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site, 1 recruiting
  • Hawassa University College of Medicine and Health Sciences

    Awasa, Sidama Region, 05

    Mr.Jember, +0468209290, devanhijember@gmail.com

    Mr. Chea, +251910149196, cheanana2007@gmail.com

    Recruiting

Other trials in Ethiopia

About this study

Official title: Improving Maternal Health Service Utilization Among Women of Reproductive Age in Sidama Regional State, Ethiopia

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.

Read more

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).

Read the detailed description

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.

Conditions
Maternal Death
Being tested
Health education
Keywords
Health education, maternal health, utilization, Ethiopia.
Medical subject headings
Maternal Death, Health Education, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health educationBehavioural

    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.

Study groups in NCT05865873
Study groupRoleWhat they receive
Interventional groupExperimentalIntervention group: will receive routine plus pre-recorded audio-based HEI package for six months until date of delivery.
Receives: Behavioral: Health education
Comparator groupActive comparatorComparator group: will receive the routine health education package for six months until the date of delivery as per the Ethiopian guidelines.
Receives: Behavioral: Health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2023
  2. Study start1 Jan 2023
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

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
Parallel-group Cluster Randomized Controlled Trial (CRCT) will be used to address the objectives of the current study. The study is a 2 arm CRCT, with every cluster being kebeles located in the Dale and Wonsho districts of Sidama region, Ethiopia. The hallmark of this design is each cluster remains in the arm it was randomly assigned to during the course of the whole study period. Thus, all study subjects are randomly assigned into a group and all the study subjects in the assigned group obtain or do not obtain an intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865873
Sponsor's protocol ID
IRB/076/15
Acronym
MHSU
Status last verified
May 2023
First submitted
3 Apr 2023
Last updated
19 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Central Statistical Agency (CSA). "[Ethiopia] and ICF," Ethiopia Minin Demographic and Health Survey 2019: Key Indicators Report: Addis Ababa, Ethiopia, and Rockville, CSA and ICF, Maryland, USA.

  • Umar NJ, Afolayan JL, Emmanuel EA, Rejuaro FM, Onasoga OA, et al. (2017) Impact of Health Education on Knowledge and Access to Delivery Care Services by Women among Edu Local Government Area, Nigeria. J Community Med Health Educ 7: 510. doi:10.4172/2161-0711.1000510

  • UM Ango, MO Oche, IS Abubakar, KJ Awosan, Kaoje AU, MO Raji. Effect of health education intervention on knowledge and utilization of health facility delivery services by pregnant women in Sokoto State, Nigeria. International Journal of Contemporary Medical Research 2018;5(6):F4-F9.

  • Jibril UN, Saleh GN, Kayode OS, Morisola RF, Umar A, et al. Impact of Health Education Intervention on Knowledge and Utilization of Postnatal Care Services among Women in Edu Local Government of Kwara State, Nigeria doi: 10.4103/2278-960X.194496

  • OKAFOR, Orji Urenna; YEWANDE, Ademuyiwa Iyabo. Effect of antenatal education on knowledge and utilization of facility-based delivery services among pregnant women in two health institutions in Alimosho, Lagos state. International Journal of Research in Medical Sciences, [S.l.], v. 8, n. 10, p. 3457-3462, sep. 2020. ISSN 2320-6012.

  • Creswell J. W, Qualitative Inquiry & Research Design: Choosing Among Five Traditions. Thousand Oaks: CA. Sag Publications, Inc. 1998.

  • World Health Organization (WHO), Maternal mortality. Available from https://www.who.int/news-room/fact-sheets/detail/maternal-mortality

  • Borde MT, Loha E, Johansson KA, Lindtjorn B. Utilisation of health services fails to meet the needs of pregnancy-related illnesses in rural southern Ethiopia: A prospective cohort study. PLoS One. 2019 Dec 4;14(12):e0215195. doi: 10.1371/journal.pone.0215195. eCollection 2019.

    PubMed 31800574
  • Borde MT, Loha E, Johansson KA, Lindtjorn B. Financial risk of seeking maternal and neonatal healthcare in southern Ethiopia: a cohort study of rural households. Int J Equity Health. 2020 May 18;19(1):69. doi: 10.1186/s12939-020-01183-7.

    PubMed 32423409
  • Borde MT, Loha E, Lindtjorn B. Incidence of postpartum and neonatal illnesses and utilization of healthcare services in rural communities in southern Ethiopia: A prospective cohort study. PLoS One. 2020 Aug 27;15(8):e0237852. doi: 10.1371/journal.pone.0237852. eCollection 2020.

    PubMed 32853242
  • Abosse Z, Woldie M, Ololo S. Factors influencing antenatal care service utilization in hadiya zone. Ethiop J Health Sci. 2010 Jul;20(2):75-82. doi: 10.4314/ejhs.v20i2.69432.

    PubMed 22434964
  • Mamuye SA. Magnitude and Determinants of Postnatal Care Service Utilization Among Women Who Gave Birth in the Last 12 Months in Northern Ethiopia: A Cross-Sectional Study. Int J Womens Health. 2020 Nov 13;12:1057-1064. doi: 10.2147/IJWH.S269704. eCollection 2020.

    PubMed 33223856
  • Geleto A, Chojenta C, Taddele T, Loxton D. Association between maternal mortality and caesarean section in Ethiopia: a national cross-sectional study. BMC Pregnancy Childbirth. 2020 Oct 6;20(1):588. doi: 10.1186/s12884-020-03276-1.

    PubMed 33023536
  • Berelie Y, Yeshiwas D, Yismaw L, Alene M. Determinants of institutional delivery service utilization in Ethiopia: a population based cross sectional study. BMC Public Health. 2020 Jul 8;20(1):1077. doi: 10.1186/s12889-020-09125-2.

    PubMed 32641020
  • Kifle D, Azale T, Gelaw YA, Melsew YA. Maternal health care service seeking behaviors and associated factors among women in rural Haramaya District, Eastern Ethiopia: a triangulated community-based cross-sectional study. Reprod Health. 2017 Jan 13;14(1):6. doi: 10.1186/s12978-016-0270-5.

    PubMed 28086926

Questions about this trial

What is this clinical trial studying?

A study testing Health education in people with Maternal Death, run by Hawassa 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 7 inclusion and 0 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 19 May 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 Mr. Tesfaye (+0468209290, devanhijember@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT05865873, which also lists 32 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 19 May 2023.

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