Maternal health and infant survival are paramount concerns globally, and Tanzania is no exception. High rates of pre-eclampsia and infant mortality have spurred the development of innovative strategies to address these pressing issues. This article delves into an mHealth (mobile health) intervention, aimed at reducing pre-eclampsia and improving infant outcomes, recently implemented in Tanzania.
Clinical Trial Overview
ClinicalTrials.gov Identifier: NCT03978429
Recruitment Status: Completed
First Posted: June 7, 2019
Last Update Posted: May 24, 2023
Sponsors and Collaborators:
– Sponsor: Queen’s University
– Collaborator: Ifakara Health Institute
– Information provided by (Responsible Party): Dr. Karen Yeates, Queen’s University
Study Description
Brief Summary:
The core of this study is a cluster randomized controlled trial (RCT) of antenatal clinics located in four districts in Tanzania. This research adopts a pragmatic approach to measure the degree of benefit under real-world conditions. The primary aim is to determine the effectiveness of implementing an mHealth strategy to enhance the detection and management of pre-eclampsia (PE). This multi-level, mixed-methods design includes a cluster-randomized controlled trial (RCT) of antenatal clinics in rural Tanzania.
The Intervention
The intervention involves implementing an mHealth strategy to improve the detection and management of pre-eclampsia. Specifically, the study focuses on the following components:
1. Community-based Pre-eclampsia/Eclampsia Detection and Management: Antenatal care nurses receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines. They are equipped with smartphones to log key indicators and activities at each ANC visit, delivery, and postnatal care visits of enrolled participants. Bluetooth blood pressure monitors are also provided to them.
2. Strengthened Referral Network from Community to Referral Hospital Levels: Community Health Workers (CHWs) within the intervention facilities receive training in pre-eclampsia features and are equipped with smartphones and access to a smartphone application. This application prompts them to initiate follow-ups with pregnant women within the community and sends SMS/text message reminders about pregnant women requiring follow-up. ANC nurses and CHWs work together to facilitate referrals and enhance community-level follow-up.
3. Real-time Data Collection and Monitoring: At all antenatal visits, pregnant women have their blood pressures measured, and urine assessed for proteinuria. The results are automatically sent by SMS with a unique patient identifier to a central site for monitoring and tracking. This real-time data collection ensures timely response and intervention.
Study Design
– Study Type: Interventional (Clinical Trial)
– Actual Enrollment: 3000 participants
– Allocation: Randomized
– Intervention Model: Parallel Assignment
– Masking: Triple (Participant, Investigator, Outcomes Assessor)
– Primary Purpose: Health Services Research
The primary outcome measure in this study is a composite indicator reflecting activities associated with the recognition and management/treatment of pre-eclampsia. This measure is evaluated at one month post-delivery and includes various criteria related to blood pressure, proteinuria, symptoms, and management practices.
In summary, this innovative mHealth intervention in Tanzania represents a promising approach to enhance maternal and infant health outcomes by improving the detection and management of pre-eclampsia in a real-world healthcare setting. The study’s design, which includes real-time data collection and a strengthened referral network, holds the potential to significantly impact maternal and infant health in Tanzania and serves as a model for similar initiatives worldwide.
