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

NCT05865873 | Unknown

• 1 other identifier: IRB/076/15
• Study Type: interventional
• Target: 1,126
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Maternal Death

Keywords

Health education, maternal health, utilization, Ethiopia.

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months

Study Arms (2)

Interventional group

EXPERIMENTAL

Intervention group: will receive routine plus pre-recorded audio-based HEI package for six months until date of delivery.

Behavioral: Health education

Comparator group

ACTIVE COMPARATOR

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

Interventions

Health education BEHAVIORAL

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.

Comparator group; Interventional group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Women of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Women who have a severe illness during the data collection period.
• Women who experienced stillbirth and infant deaths.

Sponsors & Collaborators

• Hawassa University: lead
• Universidad Pública de Navarra: collaborator

Study Sites (1)

Hawassa University College of Medicine and Health Sciences

Awasa, Sidama Region, 05, Ethiopia

RECRUITING

Related Publications (32)

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  RESULT

• Yoseph A, Teklesilasie W, Guillen-Grima F, Astatkie A. Effect of community health education on mothers' knowledge of obstetric danger signs and birth preparedness and complication readiness practices in southern Ethiopia: A cluster randomized controlled trial. PLoS One. 2024 Nov 27;19(11):e0312267. doi: 10.1371/journal.pone.0312267. eCollection 2024.

  PMID: 39602439 DERIVED

• Yoseph A, Teklesilasie W, Guillen-Grima F, Astatkie A. Community-Based Health Education Led by Women's Groups Significantly Improved Maternal Health Service Utilization in Southern Ethiopia: A Cluster Randomized Controlled Trial. Healthcare (Basel). 2024 May 18;12(10):1045. doi: 10.3390/healthcare12101045.

  PMID: 38786455 DERIVED

MeSH Terms

Conditions

Maternal Death; Health Education; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Amanuel Samago

  HAWASSA UNIVERSITY COLLEGE OF MEDICINE AND HEALTH SCIENCES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mr. Tesfaye

CONTACT

+0468209290; devanhijember@gmail.com

Mr. Chea

CONTACT

+251910149196; cheanana2007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the study intervention, neither research team members nor study respondents can be masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 19, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 30, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 09/08/2024
• Access Criteria: un on request from primary author

Locations

ET (1)