Using Advanced Data Systems to Improve Health in Early Life in Rural Nepal

NCT05697822 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2023-02-14

No results posted yet for this study

Summary

The goal of this cluster randomized controlled trial is to study the effect of a mobile-phone based application used by pregnant women on maternal and newborn health indicators. The main objective is to compare the rates of institutional deliveries in the intervention and control arms. Ancillary objectives are to compare the birth-preparedness and complication readiness parameters, severe maternal morbidity rates and neonatal adverse outcomes rates in the two arms. The participants are pregnant women.

In the intervention arm pregnant women will be given a smart mobile phone with an application that they will use to input information related to their health. This information can be shared with their healthcare workers. The healthcare workers will also be able to access all the health-related details of the pregnant women and mothers under their care by accessing this app in their mobile phones and be in touch with their patients through the mobile phone application.

The control arm will adhere to existing practices of pregnant woman and health worker communication without the use of a smart mobile phone with an existing application. Records related to the pregnant woman will be kept in paper-based forms as is the usual norm.

The investigators will compare the intervention arm and the control arm to see if there are differences in the rates of the outcomes.

Conditions

  • Maternal Health
  • Infant Health
  • Institutional Delivery
  • Birth Preparedness and Complication Readiness
  • Severe Maternal Morbidity
  • Neonatal Adverse Outcome

Interventions

OTHER

Mobile Phone and Cloud-based Electronic Contact and Recording System

A mobile phone application has been developed which is intended to be used by pregnant women and their healthcare workers. A pregnant woman can get registered in this app and enter information and data related to their health and current pregnancy. Their health worker at their health post can access this information on their mobile phone too. The pregnant woman can also input her daily symptom on this app. She can also input and/or access information on examination and tests that have been carried out. If a concerning symptom or event has been entered by a user in the app, the health worker will be notified through this app. The health worker can also track the pregnant women under their care through this application. A cloud-based database of pregnant women will have the details of all the pregnant women in a given ward or rural municipality. Health coordinators in the municipality will be able to access the database for their municipality and track the pregnant women, if needed.

Sponsors & Collaborators

  • Bagmati Rural Municipality, Lalitpur, Nepal

    collaborator UNKNOWN
  • Konjyosom Rural Municipality, Lalitpur, Nepal

    collaborator UNKNOWN
  • Mahankal Rural Municipality, Lalitpur, Nepal

    collaborator UNKNOWN
  • School of Health Sciences, Purbanchal University, Nepal

    collaborator UNKNOWN
  • Amit Arjyal

    lead OTHER

Principal Investigators

  • Ranjan P Devbhandari, MBBS,PhD · Patan Academy of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Nepal

Study Locations

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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 NCT05697822 on ClinicalTrials.gov