Effect of Mobile Health Integrated Antenatal Care Intervention

Summary

The World Health Organization (WHO) has released wide-ranging guidelines on antenatal care (ANC) with the aiming to provide ongoing maternity care and "positive pregnancy experience". In this regard, the Safe Delivery App (SDA) and Health for All App provide animated clinical instruction videos in basic emergency obstetric and neonatal care, has been developed and recommended to be implemented in maternity health care. Though mobile health (mHealth) technology shows immense potential in improving healthcare services, evidence of its effectiveness had not been previously seen in Ethiopia.

Objectives: This study aims to assess effect of mHealth integrated ANC intervention in improving maternity continuum of care utilization, obstetric health literacy, and maternal and perinatal outcomes in Public Hospitals in East Gojjam Zone, North-West, Ethiopia, 2024/2025.

Methods: an interventional two-arm pragmatic cluster randomized controlled trial (RCT) will be conducted at six (three for each arm) primary Public Hospitals in East Gojjam Zone, North-West, Ethiopia, from April 1st to December 30th 2024. About 520 (260 for each arm) low-risk pregnant women having an access to smartphones and coming for 1st ANC contact within the first 12 weeks of gestation will be identified, requested and recruited for the study in both arms. Thereafter, those eligible women in the intervention arm will receive the application and practical training of mHealth solution in addition to the routine ANC services. Data will be collected 4 times, just at the baseline, end of ANC contact, at delivery and within 7 days of post natal period through record review, client interview and observation. The quantitative data will be analyzed using a chi-squared test, independent t-test, paired t-test, intention-to-treat (ITT) and per protocol (PP) analysis. Generalized linear mixed effect modeling will be used and the intervention's effect on our pre-specified objectives will be assessed using a relative risk (RR) measure of association along with non-inferior and superior analysis. Qualitative data will be collected from both the healthcare providers and clients to experience about the acceptability, feasibility and sustainability of integrating mHealth interventions.

Expected outcomes: includes maternity continuum of care, obstetric health literacy, birth preparedness and complication readiness plan and satisfaction, maternal and perinatal outcomes

Conditions

• Maternity Continuum of Care
• Obstetric Health Literacy
• Maternal Outcomes
• Perinatal Outcomes

Interventions

DEVICE

Health for All Mobile health application

This interventional study is implemented by using Health for All Mobile health application among pregnant women in the intervention group and in the control group pregnant women were those who took the routine ANC contact . The effect of the intervention is mainly depend on the women themselves.

Sponsors & Collaborators

• Yibelu Bazezew Bitewa

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-05-10

Completion

2025-06-25

Countries

• Ethiopia