NCT07130890

Effect of Mobile Health Integrated Antenatal Care Intervention

Completed NA Last updated 19 August 2025

What this trial tests

NA trial testing Health for All Mobile health application in Maternity Continuum of Care in 520 participants. Completed in 25 June 2025.

Timeline

1 May 2024

Primary endpoint
10 May 2025

25 June 2025

Quick facts

Lead sponsor	Yibelu Bazezew Bitewa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	520
Start date	1 May 2024
Primary completion	10 May 2025
Estimated completion	25 June 2025
Sites	1 location across Ethiopia

Drugs / interventions tested

• Health for All Mobile health application

Conditions studied

• Maternity Continuum of Care — all drugs for Maternity Continuum of Care →
• Obstetric Health Literacy — all drugs for Obstetric Health Literacy →
• Maternal Outcomes — all drugs for Maternal Outcomes →
• Perinatal Outcomes — all drugs for Perinatal Outcomes →

Sponsor

Yibelu Bazezew Bitewa

Who can join

Adults 18 to 49, female only, with Maternity Continuum of Care or Obstetric Health Literacy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.