Clinical trial NCT03978429: An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania
Official title: A Cluster Randomized, Parallel-group, Superiority Study to Compare the Effectiveness of a Community-based mHealth Strategy Versus Enhanced Usual Care in the Detection and Management of Pre-eclampsia/Eclampsia in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Keywords: Pre-eclampsia
Eclampsia
mHealth
mobile health
Gestosis
Hypertension, Pregnancy-Induced
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Ifakara Health Institute
First posted: 2019-06-07
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The core of this study is a cluster randomized controlled trial (RCT) of antenatal clinics which are located in four districts in Tanzania. We are conducting an effectiveness (pragmatic) rather than an efficacy (explanatory) trial because we are looking to measure the degree of benefit under 'real world' conditions. Although pragmatic and carried out in real world conditions, the proposed size and scope of the trial will allow us to achieve a robust evaluation of outcomes and determine the effectiveness of our intervention. A cluster design is the most appropriate type of methodology (rather than individual randomization by pregnant woman) as the intervention can be delivered to the entire health facility (of those facilities in the intervention group). The intervention is to implement an mHealth strategy to improve detection and management of PE (pre-eclampsia). This study is a multi-level, mixed-methods design that includes a cluster-randomized controlled trial (RCT) of antenatal clinics in rural Tanzania. Thirty health facilities have been randomized to control facilities and thirty facilities have been randomized to intervention clinics. All randomized clinics have upgraded antenatal care (ANC) and skilled birth attendants present. Nurses in the intervention clinics in this cluster arm will receive mHealth-based education in detection and management of PE and will be instructed and encouraged to follow a guideline-driven approach supported by mHealth (educational modules that provide decision support and reminders through the facility smartphone/tablet). At all antenatal visits, pregnant women will have their blood pressures measured and urine assessed for proteinuria, and, the result will be automatically sent by SMS (short message service) with a unique patient identifier to a central site for monitoring and tracking. Community Health Workers (CHWs) linked to the facility site and local communities will be instructed on which women to have follow-up visits within their communities. For all those women found to be at risk for PE (as well as other high risk maternal conditions), an SMS will be sent to the CHW, and, the nurses at the ANC recommending timely follow-up and protocol steps for management at that facility or for transfer for further monitoring and management at a higher-level facility. The nurses participating in the study have been drawn from the health facilities themselves, in both control and intervention arms. Quantitative data will be collected on an ongoing basis through the mobile platform. Women are eligible for recruitment between 15 weeks and 36 weeks gestation.


Eligibility criteria: Inclusion Criteria:

* at least 5 months pregnant

Exclusion Criteria:

* Unable to provide consent.

Primary outcomes:
measure: Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia)
timeFrame: Outcome is evaluated at one month post delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Ifakara Health Institute
Study officials:
affiliation: Queen's University
name: Karen E Yeates, MD
role: PRINCIPAL_INVESTIGATOR
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