NCT03700034Active, not recruiting
mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal
A Cluster-randomized Trial of an mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in Primary Care Settings in India and Nepal
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1320 (actual)
- First submitted
- 4 Oct 2018
- Start date
- 10 Jul 2024
- Primary completion date
- 10 Dec 2025
- Lead sponsor
- Public Health Foundation of India
- Diseases
- High blood pressure
- NCT number
- NCT03700034
What you commit to
- Study type: Interventional
- Participants enrolled: 1320
- From 10 Jul 2024 to the primary completion date, 10 Dec 2025
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Women coming to the trial facility for a non-routine ANC visit (for example, to get a laboratory investigation, to collect a report or her medicine)
Who the study is looking for
- Pregnant women visiting a trial facility up to the end of the 28th week of gestation
- Women who are planning to remain within the five study districts until at least one-month post-partum OR women whose mothers reside in the selected districts
Age in the registry: 18 years to 49 years · Sex: Female · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Primary Health Centres (PHCs) Coordinator of this site? Confirm its status | Medak | India | Unknown status |
| Primary Health Centres (PHCs) Coordinator of this site? Confirm its status | Rangareddy | India | Unknown status |
| Primary Health Centres Coordinator of this site? Confirm its status | Siddipet | India | Unknown status |
| Primary Health Centres (PHCs) Coordinator of this site? Confirm its status | Vikārābād | India | Unknown status |
| Primary Health Centres (PHCs) Coordinator of this site? Confirm its status | Yadadri Bhuvnagiri | India | Unknown status |
| Health posts Coordinator of this site? Confirm its status | Dhulikhel | Nepal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.