Effect of Mobile Health Integrated Antenatal Care Intervention

NCT07130890 | Completed DMC

• 1 other identifier: RCSTTD/364/01/16
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mHealth, Health for All, RCT

Outcome Measures

Primary Outcomes (4)

• Continuum of maternity care

  Percent of pregnant women who utilize maternal health services continuously (adherence to the 8 ANC contacts or six uninterrupted ANC but give birth before the next contact + institutional delivery + at least one postnatal care utilization after discharge within 7 days), which was measured using a structured questionnaire

  Up to seven days of the postnatal period

• Obstetric Health Literacy

  Obstetric Health Literacy about pregnancy danger signs, birth preparedness, and complication readiness plan was measured with knowledge-related questions and categorized as good or poor based on the mean score of the questions.

  40 weeks of pregnancy

• Maternal health outcomes

  The percentage (%) of pregnant women who have good or bad maternal health outcomes, considering major pregnancy, childbirth, and early postnatal complications, measured via a structured questionnaire.

  Up to seven days of post postpartum period

• Perinatal outcomes

  The percentage (%) of pregnant women who have good or bad perinatal outcomes, considering gestational age during delivery, stillbirth, birth weight, perinatal Birth asphyxia, Neonatal Intensive Care unit admission, and early neonatal deaths, measured by a structured questionnaire

  Up to seven days of post postpartum period

Study Arms (2)

two arms

ACTIVE COMPARATOR

This is a Two arm pragmatic RCT study( one intervention and one control group). The intervention group was pregnant women who assigned to use Health for all mobile health application in addition to the routine ANC contact and the control group was those pregnant women allowed to continue only the routine ANC contact.

Device: Health for All Mobile health application

Control arm

NO INTERVENTION

pregnant women in the control arm were those who took the routine ANC follow up without additional intervention

Interventions

Health for All Mobile health application DEVICE

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.

two arms

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Low-risk pregnant women
• Pregnant women having access to a smartphone
• Coming for the 1st ANC contact within the first 12 weeks of gestation
• Willing to participate in the study

You may not qualify if:

• High-risk pregnant women
• Pregnant women who have no access to a smartphone
• Those pregnant women coming for the 1st ANC contact after 12 weeks of gestation
• Unwilling to participate in the study

Sponsors & Collaborators

• Yibelu Bazezew Bitewa: lead

Study Sites (1)

College of Medicine and Health Science, Debre Marcos University

Debre Markos, Amhara Regional State, 269, Ethiopia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: May 1, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 25, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As requested
• Access Criteria: All scholars can access it by request or in the journal when it is published.

Locations

ET (1)