mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal

NCT03700034 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1320

Last updated 2026-05-14

No results posted yet for this study

Summary

Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). This intervention -"mIRA" - is an mHealth integrated model of hypertension, diabetes, and antenatal care in primary care settings. mIRA aims to (a) prompt frontline health workers (FHWs) to provide evidence-based routine ANC, and also enhance the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia, whilst improving adherence to National ANC guidelines; (b) facilitate record-keeping and reporting and; (c) link providers across various levels of care to improve continuity of care.

A cluster randomized controlled (cRCT) to assess the effectiveness of the mIRA EDSS in improving ANC and enhancing the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia will be conducted in Telangana, India. A mixed-methods process evaluation will be conducted in both India and Nepal. The process evaluation will contribute to our understanding of the mechanisms contributing to changes (improvement) in the quality of ANC by using the EDSS intervention.

Conditions

  • Gestational Diabetes Mellitus (GDM)
  • Pregnancy Induced Hypertension (PIH)
  • Anemia

Interventions

OTHER

mHealth Integrated Model of Antenatal Care

In the intervention facilities, antenatal care (ANC) will be provided to all pregnant women using the mIRA electronic decision support system (EDSS) by ANMs (Auxiliary Nurse Midwife), Staff nurses, or Medical Officers (MOs). These frontline healthcare workers (FHWs) will be trained to use the EDSS and will also be provided "refresher" training on the guideline-recommended processes of ANC. This training will enable them to use the mIRA EDSS in the provision of ANC. Non-physician FHWs (ANMs and staff nurses) will screen, detect, and refer PIH, GDM, and severe anemia cases. They will not prescribe treatments, but will carry out all other duties including diagnosis, referral to the MO to prescribe drugs, provide lifestyle advice, follow-up, and subsequently support adherence to management plans.

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • Kathmandu University School of Medical Sciences

    collaborator OTHER
  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • Public Health Foundation of India

    lead OTHER

Principal Investigators

  • Dorairaj Prabhakaran, DM · Vice President, Research and Policy

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-12-10
Completion
2026-09-01

Countries

  • India
  • Nepal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700034 on ClinicalTrials.gov