Preeclampsia Clinical Trial
Official title:
Feasibility of Implementing a Mobile Phone-based Telemonitoring Program to Support Pregnant Women at High-risk for Preeclampsia in Karachi, Pakistan
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | March 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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] Exclusion Criteria: - Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Health Network, Toronto | Aga Khan University, Jinnah Postgraduate Medical Centre, University of Toronto |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Alerts | Total Number of Urgent Alerts (n), Total Number of Non-Urgent Alerts (n), Total Number of Normal Readings (n), Total Number of Red Alerts for Each Woman (n), Total Number of Yellow Alerts for Each Woman (n), | At study completion, approximately 1 year | |
Other | Mean systolic and diastolic blood pressure | Mean systolic blood pressure (mmhg), Mean diastolic blood pressure (mmhg) | At study completion, approximately 1 year | |
Primary | 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 (%) | At study completion, approximately 1 year | |
Primary | Demand | Number of Women Consented to Participate in Raabta Program (n), Total Number of Women Enrolled in the Raabta Program (n), Number of Women Decided to Leave the Raabta Program (n), Number of Women Adhered to the Program Until Delivery (n), Length of time each patient enrolled with program/Duration of TM (Weeks), Number of Logins for Each Woman (n), and Total Number of Logins for All Enrolled Women (n) | At study completion, approximately 1 year | |
Primary | Practicality | Total Number of Calls Made by Medical Officer/Nurse to Each Woman (n), Total Number of Calls Made by Medical Officer/Nurse to All Enrolled Women (n), Total Number of Calls Made by Each Woman to Medical Officer/Nurse (n), Total Number of Calls Made by Enrolled Women (n), Total Number of Emails Received by Medical Officer/Nurse for Alerts (n), Total Number of Request for Changes in Raabta Program (n), and Total Number of Calls Received by Medical Officer/Nurse for Technical Support (n) | At study completion, approximately 1 year | |
Primary | Fidelity | Total Number of Request for Changes in Raabta Program (n) | At study completion, approximately 1 year | |
Secondary | Clinical efficacy | Presence of PE symptoms (Yes/No), Presence of Gestational Hypertension (Yes/No), Presence of Preeclampsia at Delivery (Yes/No), Presence of Eclampsia at Delivery (Yes/No), Presence of HELLP Syndrome (Yes/No), and Presence of Suspected Fetal Growth Restriction (Yes/No) | At study completion, approximately 1 year |
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