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

Primary Purpose

Maternal Death

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Health education
Sponsored by
Hawassa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Death focused on measuring Health education, maternal health, utilization, Ethiopia.

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hawassa University College of Medicine and Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Comparator group

Arm Description

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

Comparator group: will receive the routine health education package for six months until the date of delivery as per the Ethiopian guidelines.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
May 16, 2023
Sponsor
Hawassa University
Collaborators
Universidad Pública de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT05865873
Brief Title
Maternal Health Service Utilization Among Women of Reproductive Age in Sidama Region, Ethiopia
Acronym
MHSU
Official Title
Improving Maternal Health Service Utilization Among Women of Reproductive Age in Sidama Regional State, Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawassa University
Collaborators
Universidad Pública de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Death
Keywords
Health education, maternal health, utilization, Ethiopia.

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Because of the nature of the study intervention, neither research team members nor study respondents can be masked.
Allocation
Randomized
Enrollment
1126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Intervention group: will receive routine plus pre-recorded audio-based HEI package for six months until date of delivery.
Arm Title
Comparator group
Arm Type
Active Comparator
Arm Description
Comparator group: will receive the routine health education package for six months until the date of delivery as per the Ethiopian guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women of reproductive age
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Tesfaye
Phone
+0468209290
Email
devanhijember@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Chea
Phone
+251910149196
Email
cheanana2007@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanuel Samago
Organizational Affiliation
HAWASSA UNIVERSITY COLLEGE OF MEDICINE AND HEALTH SCIENCES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawassa University College of Medicine and Health Sciences
City
Hawassa
State/Province
Sidama Region
ZIP/Postal Code
05
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mr.Jember
Phone
+0468209290
Email
devanhijember@gmail.com
First Name & Middle Initial & Last Name & Degree
Mr. Chea
Phone
+251910149196
Email
cheanana2007@gmail.com
First Name & Middle Initial & Last Name & Degree
Amanuel Samago, Master

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Maternal Health Service Utilization Among Women of Reproductive Age in Sidama Region, Ethiopia

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