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

May 16, 2023 updated by: Amanuel Yoseph Samago, Hawassa University

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
    • Sidama Region
      • Hawassa, Sidama Region, Ethiopia, 05
        • Recruiting
        • Hawassa University College of Medicine and Health Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanuel Samago, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Intervention group: will receive routine plus pre-recorded audio-based HEI package for six months until date of delivery.
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.
Active Comparator: Comparator group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawassa University

Collaborators

Universidad Pública de Navarra

Investigators

  • Principal Investigator: Amanuel Samago, Hawassa University College of Medicine and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/076/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

09/08/2024

IPD Sharing Access Criteria

un on request from primary author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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