PreeclampsiaNCT05662696
Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan
A study testing Raabta Telemonitoring Program (Mobile Application) in people with Preeclampsia and Pregnant With Complication, run by University Health Network, Toronto at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Pregnant With Complication
- What is being tested?
- Raabta Telemonitoring Program (Mobile Application)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Aug 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Postgraduate Medical Centre
Karachi, Sindh, 75510
Haleema Yasmin, +92 21 99201300, dr.haleemayasmin@yahoo.com
About this study
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.
Read the detailed description
Previous studies in LMICs have implemented telemonitoring by community health workers as part of the Community-Level Interventions for Preeclampsia (CLIP) trial and Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan, and Sri Lanka [COBRA-BPS] studies. These telemonitoring interventions relied on community health workers to record vital signs on a mobile application during in-person visits, which can miss signs of health issues during physical visits by the community health workers and can also introduce white coat hypertension or masked hypertension. The objective of this study is to enable early risk detection, diagnosis, and treatment of pregnant women at high-risk for preeclampsia between antenatal visits and to provide more frequent data than what can be achieved with home visits by community health workers.
The study intervention will be the telemonitoring program for high-risk pregnant women, which will be delivered using the telemonitoring platform. The telemonitoring program is named "Raabta" which means 'a connection' in Urdu. The Raabta technology has been developed at the Centre for Digital Therapeutics, University Health Network in Toronto, Canada. Hosting of the telemonitoring platform and storage of the patient data will be at the Centre for Digital Therapeutics, University Health Network.
The patient-facing technology includes the Raabta smartphone application (app). The app will enable pregnant women to take daily blood pressure readings at home with a provided Bluetooth-enabled home blood pressure monitor and to receive automated alerts (i.e., self-care messages) via the app. The app will use a rules-based algorithm which is developed using NICE guidelines and consultations from expert clinicians. The algorithm includes settings to trigger alerts and self-care messages for high-risk pregnant women with or without antihypertensives and symptoms of preeclampsia (e.g., instructing patients to repeat blood pressure readings, call a medical officer, visit the emergency department, etc.). Other features of the Raabta app include the use of local language (Urdu), illustrations for daily symptom monitoring questions (for pregnant women who cannot read), an easy-to-understand green-yellow-red alert system that uses the well-known traffic lights analogy, and voice message alerts in conjunction with the text.
The clinician-facing technology includes the web-based Raabta dashboard. To support clinical decision-making, the medical officer situated at the JPMC OB-GYN outpatient department will receive alerts from the telemonitoring system if the patient's blood pressure trends are out of the target or if the patient is reporting symptoms. The medical officer will act as a central point person to communicate with the patients (phone calls or using the asynchronous telemonitoring system chat feature) and with the rest of the participant's care team as needed.
- Conditions
- Preeclampsia, Pregnant With Complication
- Being tested
- Raabta Telemonitoring Program (Mobile Application)
- Keywords
- Telemonitoring, mHealth, Remote monitoring
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raabta Telemonitoring Program (Mobile Application)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in Pakistan | Experimental | The study intervention includes a telemonitoring program for high-risk pregnant women, which will be delivered using the telemonitoring platform. The trial will administer the telemonitoring program to 50 pregnant women at high risk for preeclampsia. The intervention will enable pregnant women to take daily blood pressure readings at home with a provided Bluetooth-enabled home blood pressure monitor, to report if participants have symptoms, and to receive automated alerts and self-care messages (e.g., instructing patients to repeat blood pressure readings, call a medical officer, visit the emergency department, etc.). A healthcare provider (medical officer) will receive alerts from the telemonitoring system if the patient's blood pressure trends are out of the target or if the patient is reporting symptoms. Receives: Other: Raabta Telemonitoring Program (Mobile Application) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: At study completion, approximately 1 year
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)
Measured: At study completion, approximately 1 year
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)
Measured: At study completion, approximately 1 year
Fidelity
Total Number of Request for Changes in Raabta Program (n)
Measured: At study completion, approximately 1 year
Secondary outcomes (1)
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)
Measured: At study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start4 Aug 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre, Aga Khan University, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Emily Seto, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662696
- Sponsor's protocol ID
- 22-5220
- Status last verified
- Apr 2026
- First submitted
- 7 Oct 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shahil Feroz A, Yasmin H, Saleem S, Bhutta Z, Seto E. Feasibility of implementing a mobile phone-based telemonitoring programme to support pregnant women at high-risk for pre-eclampsia in Karachi, Pakistan: protocol for a mixed-methods study. BMJ Open. 2022 Dec 30;12(12):e070535. doi: 10.1136/bmjopen-2022-070535.
PubMed 36585144
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing a Mobile Phone-based Telemonitoring Program to Support Pregnant Women at High-risk for Preeclampsia in Karachi, Pakistan
- ClinicalTrials.gov ID
- NCT05662696
- Acronym / sponsor ID
- 22-5220
- Conditions
- Preeclampsia, Pregnant With Complication
- Keywords
- Telemonitoring, mHealth, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre, Aga Khan University, University of Toronto
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Previous studies in LMICs have implemented telemonitoring by community health workers as part of the Community-Level Interventions for Preeclampsia (CLIP) trial and Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan, and Sri Lanka [COBRA-BPS] studies. These telemonitoring interventions relied on community health workers to record vital signs on a mobile application during in-person visits, which can miss signs of health issues during physical visits by the community health workers and can also introduce white coat hypertension or masked hypertension. The objective of this study is to enable early risk detection, diagnosis, and treatment of pregnant women at high-risk for preeclampsia between antenatal visits and to provide more frequent data than what can be achieved with home visits by community health workers.
The study intervention will be the telemonitoring program for high-risk pregnant women, which will be delivered using the telemonitoring platform. The telemonitoring program is named "Raabta" which means 'a connection' in Urdu. The Raabta technology has been developed at the Centre for Digital Therapeutics, University Health Network in Toronto, Canada. Hosting of the telemonitoring platform and storage of the patient data will be at the Centre for Digital Therapeutics, University Health Network.
The patient-facing technology includes the Raabta smartphone application (app). The app will enable pregnant women to take daily blood pressure readings at home with a provided Bluetooth-enabled home blood pressure monitor and to receive automated alerts (i.e., self-care messages) via the app. The app will use a rules-based algorithm which is developed using NICE guidelines and consultations from expert clinicians. The algorithm includes settings to trigger alerts and self-care messages for high-risk pregnant women with or without antihypertensives and symptoms of preeclampsia (e.g., instructing patients to repeat blood pressure readings, call a medical officer, visit the emergency department, etc.). Other features of the Raabta app include the use of local language (Urdu), illustrations for daily symptom monitoring questions (for pregnant women who cannot read), an easy-to-understand green-yellow-red alert system that uses the well-known traffic lights analogy, and voice message alerts in conjunction with the text.
The clinician-facing technology includes the web-based Raabta dashboard. To support clinical decision-making, the medical officer situated at the JPMC OB-GYN outpatient department will receive alerts from the telemonitoring system if the patient's blood pressure trends are out of the target or if the patient is reporting symptoms. The medical officer will act as a central point person to communicate with the patients (phone calls or using the asynchronous telemonitoring system chat feature) and with the rest of the participant's care team as needed.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in Pakistan | Experimental | Other: Raabta Telemonitoring Program (Mobile Application)The study intervention includes a telemonitoring program for high-risk pregnant women, which will be delivered using the telemonitoring platform. The trial will administer the telemonitoring program to 50 pregnant women at high risk for preeclampsia. The intervention will enable pregnant women to take daily blood pressure readings at home with a provided Bluetooth-enabled home blood pressure monitor, to report if participants have symptoms, and to receive automated alerts and self-care messages (e.g., instructing patients to repeat blood pressure readings, call a medical officer, visit the emergency department, etc.). A healthcare provider (medical officer) will receive alerts from the telemonitoring system if the patient's blood pressure trends are out of the target or if the patient is reporting symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (1 listed)
- Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raabta Telemonitoring Program (Mobile Application)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. | Other | Telemonitoring Program for Pregnant Women at High Risk for Preeclampsia in Pakistan |
Primary outcome
Acceptability
Time frame: At study completion, approximately 1 year
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 (%)
Demand
Time frame: At study completion, approximately 1 year
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)
Practicality
Time frame: At study completion, approximately 1 year
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)
Fidelity
Time frame: At study completion, approximately 1 year
Total Number of Request for Changes in Raabta Program (n)
1 secondary outcome
Clinical efficacy
Time frame: At study completion, approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 36585144Shahil Feroz A, Yasmin H, Saleem S, Bhutta Z, Seto E. Feasibility of implementing a mobile phone-based telemonitoring programme to support pregnant women at high-risk for pre-eclampsia in Karachi, Pakistan: protocol for a mixed-methods study. BMJ Open. 2022 Dec 30;12(12):e070535. doi: 10.1136/bmjopen-2022-070535.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Seto, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raabta Telemonitoring Program (Mobile Application) in people with Preeclampsia and Pregnant With Complication, run by University Health Network, Toronto at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Seto, PhD (416-669-9295, emily.seto@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: At study completion, approximately 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.