Mobile Health Strategies for Postpartum Hypertension
(SMART BP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods for managing high blood pressure after childbirth. It seeks to determine which method better improves blood pressure and heart health while empowering new mothers to feel more in control of their health. The trial includes two groups: one using a more hands-on approach (high-touch blood pressure management) and another using a less involved approach (low-touch blood pressure management). Women who have given birth within the past two weeks, were diagnosed with high blood pressure during or immediately after pregnancy, and are currently taking blood pressure medication may be suitable candidates. Participants must speak English or Spanish and be able to text on their phones.
As an unphased trial, this study provides a unique opportunity for new mothers to contribute to important research that could enhance postpartum care.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications. However, if you are using three or more blood pressure medications, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown promising results for hands-on blood pressure management. A 2023 study with over 1,000 participants found that those using this method were less likely to experience seizures, indicating it is well-tolerated. Additionally, better blood pressure control was linked to fewer emergency room visits for high blood pressure, suggesting its safety.
For less hands-on blood pressure management, studies have also shown positive outcomes. Women who managed their own blood pressure after experiencing high blood pressure during pregnancy had better heart health years later, indicating the method's long-term effectiveness and safety. Another study found that improved blood pressure control led to fewer emergency visits, further supporting its safety and effectiveness.
Both hands-on and less hands-on strategies aim to enhance blood pressure management, reducing health risks without major safety concerns.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative mobile health strategies to manage postpartum hypertension, a condition typically treated with medications like labetalol or nifedipine. Unlike conventional methods that often focus on medication adjustments alone, this trial introduces high-touch and low-touch blood pressure management. The high-touch approach involves frequent interactions with healthcare providers through digital platforms, ensuring personalized and timely care. In contrast, the low-touch method leverages automated systems for monitoring and feedback, offering a more independent management option. These strategies could lead to more effective, accessible, and patient-friendly ways to control blood pressure after childbirth.
What evidence suggests that this trial's treatments could be effective for postpartum hypertension?
This trial will compare high-touch and low-touch blood pressure management strategies for postpartum hypertension. Research has shown that both methods effectively manage high blood pressure after childbirth. Participants in the high-touch management arm will receive more frequent check-ins and support, helping to prevent serious blood pressure problems in new mothers and improve heart health. Meanwhile, studies have found that those in the low-touch management arm, with fewer check-ins, lower diastolic blood pressure by 4.5mmHg up to six months after giving birth. Both methods aim to improve heart health and reduce emergency visits due to high blood pressure.13678
Who Is on the Research Team?
Jennifer Lewey, MD, MPH
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for individuals who have recently given birth and are experiencing high blood pressure or pre-eclampsia. Participants should be postpartum and looking to manage their hypertension effectively.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Initial Assessment
Participants are randomized into high-touch or low-touch blood pressure management strategies and initial assessments are conducted
Treatment
Participants receive postpartum blood pressure management through mobile health strategies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- High-touch blood pressure management
- Low-touch blood pressure management
Trial Overview
The study compares two strategies for managing blood pressure after childbirth: a 'high-touch' approach with more direct interaction and support, versus a 'low-touch' method that's less intensive. The goal is to see which one better improves BP, heart health, and patient engagement.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Lewey, MD, MPH
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Citations
Clinical Outcomes Associated With a Remote Postpartum ...
This was a retrospective cohort study of postpartum individuals with HDP delivering from 3/2019–6/2023 at a single institution. The primary ...
Randomized Controlled Trial of Two Mobile Health ...
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure ... Other : High-touch blood pressure ...
Advances in postpartum hypertension management
In this review, we will discuss the importance of the postpartum timeframe in maternal CVH, the multidisciplinary structure of postpartum ...
Driving down postpartum high blood pressure
A new $12.5 million study aims to improve long-term cardiovascular health for patients with hypertensive disorders during pregnancy.
Postpartum Health-Care Utilization and Blood Pressure ...
Upon analysis of home postpartum BP data, we found that the proportion of blood pressures in the severe range by each postpartum day was higher ...
Postpartum management of hypertensive disorders of ...
In this review we describe postpartum HDP management among six large academic U.S. hospital systems: Medical College of Wisconsin, University of ...
Severe Hypertension In Pregnancy | AIM
The Severe Hypertension in Pregnancy patient safety bundle was revised in 2022 to incorporate respectful care concepts, revise existing elements, ...
Management of Postpartum Preeclampsia and ...
Tighter blood pressure control was associated with reduced postpartum Emergency Department visits for hypertensive disorders.
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