NCT05716178

Brief Summary

Community education and demand generation activities by involving family members, traditional and religious leaders in maternal health behaviours are potential solutions. Knowledge about maternal and neonatal health service utilization can be increased through community-based structures, such as religious organizations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

January 21, 2023

Last Update Submit

February 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Proportion of skilled delivery service utilization

    Proportion of skilled delivery service utilization will be measured based on women who gave birth in health center and hospital by assistance of health professionals that have midwifery skills including Midwife nurse, Nurse, Health Officers and Doctors as reported by the participant.

    one month

  • Proportion of antenatal care service utilization

    Proportion of antenatal care service utilization will be measured based on "at least one ANC attendance" (Women who have attended at least one ANC check-up during their current pregnancy) and "four or more ANC attendance" (Women who attended four or more ANC visits) during their current pregnancy as reported by the participant.

    one month

Secondary Outcomes (3)

  • Proportion of knowledge of major obstetric danger signs

    one month

  • proportion of perception of pregnancy risk

    one month

  • Proportion of birth preparedness and complication readiness

    one month

Study Arms (2)

Maternal health education

EXPERIMENTAL

participants in the intervention group will receive behavioral change communication on maternal health from trained religious leaders. The local religious leaders from each clustered kebele will be recruited based on religious educational status (educational status greater than or equal to diploma), acceptance by their followers and popularity, in collaboration with religious organization leaders, health extension workers, and kebele leaders. Then after the potential religious leaders are recruited, the two days training will be given for them. Recruited religious leaders are expected to give training on the topics (maternal health) for four sessions to promote healthy maternal behaviors for the members of their religion. After training sessions, every participant will receive a copy of the visual materials (posters) containing the key messages for promoting prenatal health behaviors.

Behavioral: Maternal health education

Usual or routine care

NO INTERVENTION

The control group in this study will be on the existing routine maternal service without a provision of religious leaders' training intervention. In this arm, there will be no intervention by the researchers, rather baseline and end line data will be collected.

Interventions

The local religious leaders from each clustered kebele will be recruited based on religious educational status (educational status greater than or equal to diploma), acceptance by their followers and popularity, in collaboration with religious organization leaders, health extension workers, and kebele leaders. Then after the potential religious leaders are recruited, the two days training will be given for them. Recruited religious leaders are expected to give training on the topics (maternal health) for four sessions to promote healthy maternal behaviors for the members of their religion.

Maternal health education

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women less than 20 weeks gestational age
  • Living in selected kebele (small administrative unit in Ethiopia)
  • Pregnant women willing to participate in the study

You may not qualify if:

  • Pregnant women who are seriously ill and unable to communicate will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadiya Zone

Awasa, Southern Nations, Nationalities, and Peoples' Region, Ethiopia

RECRUITING

Related Publications (1)

  • Sadore AA, Kebede Y, Birhanu Z. Effectiveness of engaging religious leaders in maternal health education for improving maternal health service utilization in Ethiopia: cluster randomized controlled trial. Front Public Health. 2024 Jul 29;12:1399472. doi: 10.3389/fpubh.2024.1399472. eCollection 2024.

Study Officials

  • Yohannes Kebede, PhD

    Jimma University

    STUDY DIRECTOR

Central Study Contacts

Abinet A Sadore, Master

CONTACT

Yohannes Kebede, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The intervention will be single-blinded. The outcome assessors will be masked.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study will have two arms, i.e., intervention and control groups. The intervention group is assigned to receive training from religious leaders on maternal and neonatal health and the control group will be left to continue the routine practices.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2023

First Posted

February 8, 2023

Study Start

March 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Baseline characteristics, outcome measure and statistical analysis

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations