NCT07095296

Brief Summary

This clinical study aims to find out if a redesigned health education program-one that respects local cultural beliefs and is based on well-known behavior change theories-can help improve how well mothers care for their newborns and how often they use postnatal care services. The main hypothesis is that culturally tailored health education provided by trained midwives will lead to: 1. Increased use of postnatal care services by mothers after childbirth, and 2. Improved knowledge among mothers about how to care for their newborns. In the study, midwives will first be trained in how to provide this culturally appropriate health education. Then, the trained midwives will deliver four health education sessions-once a month-to pregnant women during their regular antenatal (before birth) visits at health facilities.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
864

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

July 8, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

Same day

First QC Date

July 8, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

PNCCounselingHealth educationNewborn careCluster Randomized Trial

Outcome Measures

Primary Outcomes (1)

  • Postnatal care use

    PNC utilization will be assessed based on the World Health Organization (WHO) recommendations, which define adequate postnatal care as having four scheduled contacts: within 24 hours of birth, on Day 3 (48-72 hours), between Days 7-14, and at six weeks postpartum. Data will be collected using a structured maternal postnatal care follow-up questionnaire administered during endline interviews. This questionnaire includes items capturing self-reported timing and number of PNC visits, supplemented by verification from clinic records where available. For the primary analysis, PNC utilization will be coded as a binary variable: 1 (Yes) - if the mother attended at least two postnatal care visits and 0 (No) - if the mother attended fewer than two visits. This threshold reflects a more feasible level of access in the study setting. For the secondary analysis, attendance of all four WHO-recommended visits will be assessed as an indicator of higher adherence to WHO standards.

    From birth to the end of postnatal period(6th week)

Secondary Outcomes (1)

  • Newborn care knowledge

    From birth to the end of fourth week

Study Arms (2)

control

NO INTERVENTION

The control group will not receive the culturally tailored intervention. Instead, participants in this group will receive the standard routine antenatal care and postnatal health education currently provided at health facilities.

intervention

EXPERIMENTAL

Women in the experimental group will receive four educational sessions, each lasting approximately 15 to 20 minutes, delivered after the completion of routine ANC services. The sessions will be conducted in small groups, with one midwife assigned to every five pregnant women, and included verbal interaction, video presentations, and practical demonstrations.

Behavioral: Health Education

Interventions

The intervention-a culturally tailored and redesigned health education-will be guided by established behavioral theories, namely the Theory of Planned Behavior (TPB) and Social Cognitive Theory (SCT) and implemented in a culturally sensitive manner. The TPB focuses on attitudes toward utilizing PNC services, the influence of subjective norms such as cultural norm, and their perceived behavioral control including transportation (34), while SCT emphasizes self-efficacy, social modeling, and reinforcement(35). Both TPB and SCT have been extensively validated in various health behavior studies, supporting their relevance and applicability in this context(36, 37). Our intervention will consist of a structured training foe health extension worker and mentorship program. The intervention package, including the training curriculum and implementation manual, will be developed in accordance with guidelines from the World Health Organization (WHO) and the Federal Ministry

intervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Mothers who plan to relocate from the selected cluster area before or shortly after delivery
  • Mothers who do not speak either Afan Oromo or Amharic, as these are the languages used for delivering the intervention.
  • Mothers who have already completed all recommended postnatal care visits during their most recent previous birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Firew Tiruneh Tiyare, PhD candidate

CONTACT

Prof. Dr. Günther Fink, Ph.D. in economics

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is designed as a two-arm cluster randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 31, 2025

Study Start

December 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. This decision is based on the need to protect participant privacy and confidentiality, as the dataset contains sensitive health information that cannot be fully de-identified without compromising data integrity. Additionally, the consent form and ethical approval for this study do not include provisions for public sharing of raw participant-level data. Summary results, however, will be shared in line with WHO and ClinicalTrials.gov requirements.