Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan

ConditionsPreeclampsia Pregnant With Complication

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity Health Network, Toronto

About this trial

High maternal mortality from preeclampsia/eclampsia results from a lack of early identification and management of pregnant women at high risk for preeclampsia. A potential tool to support pregnant women at high risk for preeclampsia is telemonitoring. Most telemonitoring interventions have been implemented in high-income countries and thus there is limited evidence on the use and effectiveness of telemonitoring for pregnant women in low-middle-income countries (LMICs). The scarce evidence on the feasibility of telemonitoring program implementation limits the understanding of the process and mechanisms through which the intervention works in LMICs. The study will explore the feasibility of implementing a mobile phone-based telemonitoring program for pregnant women at high-risk for preeclampsia in Karachi, Pakistan. The study will be conducted at the Jinnah Post Graduate Medical Center in Karachi, Pakistan.

The study will use a mixed-methods design to recruit 50 pregnant women at high risk for preeclampsia to assess clinical feasibility across the five foci of Bowen's framework including acceptability, demand, implementation, practicality, and limited-efficacy testing. Data sources will include semi-structured interviews with the patients, and clinicians, as well as data from paper medical records, research logs, and server data. The results of the quantitative and qualitative data will be analyzed separately and then integrated at the interpretation and reporting levels to advance our understanding of the telemonitoring program's feasibility. This will be the first study to provide evidence on the feasibility of using a telemonitoring program where pregnant women at high-risk for preeclampsia in Pakistan will take their own blood pressure readings at home.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women at high-risk for preeclampsia (HRPE) who are either in their first or second trimester of pregnancy. The definition of HRPE will follow that of the NICE guidelines that define pregnant women at HRPE as those who have one high-risk factor or more than one moderate risk factor for preeclampsia.

Participants who can speak and read (at least at a rudimentary level with help from a caregiver) the Urdu language for ease of communication with the research team and to be able to use the telemonitoring system.

Partners (almost always male husbands in the Pakistani culture) and/or other caregivers (e.g., mother and mother-in-law) of pregnant women [for post-study interviews]

Clinicians and nurses involved in the implementation of the telemonitoring program [for post-study interviews]

Disqualifiers

Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition

Trial design

Design model

Single group

Treatments tested in this trial

Raabta Telemonitoring Program (Mobile Application)
Other intervention
Raabta is a smartphone application that will allow pregnant women at high-risk for preeclampsia to measure and record daily blood pressure readings and self-reported symptoms. An algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated alert self-care message based on their measurements and reported symptoms.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in PakistanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Acceptability

Rate of BP Task Compliance for Each Woman (BP readings aimed/sent by women), Rate of Symptom Task Compliance for Each Woman (Symptom readings aimed/sent by women), Compliance of all intended measurements for Each Woman (readings aimed/sent by women) (%), Month-wise Adherence of All Intended Measurements Rate for Each Women (%), Average Overall Adherence Rate of All Intended Measurements for Enrolled Women (%), and Month-wise Overall Adherence Rate of All Intended Measurements for Enrolled Women (%)

Time frame