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

Maternal Death Clinical Trial

— MHSU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865873
• Other study ID #: IRB/076/15
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Hawassa University
• Contact: Mr. Tesfaye
• Phone: +0468209290
• Email: devanhijember[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1126
• Est. completion date: September 30, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Death

Intervention

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.

Locations

Country	Name	City	State
Ethiopia	Hawassa University College of Medicine and Health Sciences	Hawassa	Sidama Region

Sponsors (2)

Lead Sponsor	Collaborator
Hawassa University	Universidad Pública de Navarra

Country where clinical trial is conducted

Ethiopia, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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