Thriving Hearts Program for High Blood Pressure During Pregnancy

Overseen By Quintana Stewart, MPA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Age, Location, Language, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant individuals with high blood pressure live healthier lives by offering extra support and resources. Taking place in ten North Carolina counties, it tests a new care approach focused on preventing high blood pressure issues during pregnancy. The trial compares usual care with enhanced care through the Thriving Hearts program, which provides additional support for both patients and healthcare providers. Individuals who are pregnant or less than four months postpartum and reside in one of the participating counties can join. As an unphased trial, participants can benefit from innovative care approaches and contribute to improving maternal health.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that the Thriving Hearts program is safe for pregnant individuals?

Research has shown that the Thriving Hearts Program is designed to help mothers manage high blood pressure during pregnancy. This new program aims to reduce long-term heart risks associated with pregnancy-related high blood pressure. While specific side effects from the Thriving Hearts Program have not been documented, it offers a community-based approach with screening and support for pregnant women at high risk.

As this is not a medication-based treatment, traditional drug-related side effects are less of a concern. Instead, the program provides resources and support to help participants manage their health more effectively. Those considering joining the program can be assured that its goal is to improve overall well-being and health during and after pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Thriving Hearts Program because it offers a comprehensive approach to managing high blood pressure during pregnancy, unlike traditional treatments that typically focus on medication alone. This program enhances standard care by equipping healthcare providers with resources to address secondary trauma and provides proactive social and material support, which are not usually part of current treatment options. By integrating these components, Thriving Hearts aims to prevent hypertensive disorders of pregnancy more effectively and support overall maternal health, which could lead to better outcomes for both mothers and babies.

What evidence suggests that the Thriving Hearts program is effective for high blood pressure during pregnancy?

Research has shown that community-based maternity care programs can lower the risk of high blood pressure during pregnancy. In this trial, participants in the post-intervention arm will receive care enhanced with Thriving Hearts components, which include lifestyle changes like diet and exercise. Early results suggest that Thriving Hearts might reduce high blood pressure cases by about 20%. This program also equips healthcare providers with tools to manage stress and offers social support to pregnant individuals. Studies on similar programs have demonstrated better outcomes for both parents and babies, highlighting the potential of this approach. Overall, the evidence suggests that Thriving Hearts could effectively manage and reduce high blood pressure during pregnancy. ^{1 2 5 6 7}

Who Is on the Research Team?

Alison M Stuebe, MD, MSc

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for pregnant individuals or those giving birth who are at risk of high blood pressure disorders like preeclampsia. Participants will be from ten North Carolina counties and must receive care through Local Health Departments involved in the study.

Inclusion Criteria

Individual who is pregnant or ≤4 months postpartum and resides in a county where Thriving Hearts is active can engage with Thriving Hearts-supported programs and services

I can communicate in English or Spanish.

Had a live birth at ≥24 weeks in the past 6 months

Exclusion Criteria

I am younger than 15 or older than 55.

Residential address not listed on birth certificate as one of the study counties

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care Phase

Participating LHDs provide usual care before transitioning to the Thriving Hearts program

9 months

Intervention Phase

Implementation of the Thriving Hearts program, including point-of-care HDP prevention and enhanced support

9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thriving Hearts

Trial Overview The Thriving Hearts program aims to reduce pregnancy-related high blood pressure complications by providing enhanced support at individual, healthcare provider, and community levels. It's a stepped-wedge, cluster randomized study comparing usual care with the Thriving Hearts intervention.

How Is the Trial Designed?

Group I: Post-intervention Active Control 1 Intervention

In the post-intervention sequence(s), pregnant and parenting people in participating counties will experience care enhanced with Thriving Hearts components, including point-of-care HDP prevention, health care providers equipped with resources for coping with secondary trauma, and proactive provision of social and material support.

Group II: Pre-intervention Placebo Group 1 Intervention

In the pre-intervention sequence(s), pregnant and parenting people in participating counties will experience treatment-as-usual.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Piedmont Health Services, Inc.

Collaborator

Trials

1

Recruited

17,500+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

The North Carolina Alliance of Public Health Agencies, Inc.

Collaborator

Trials

1

Recruited

17,500+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Orange County Health Department

Collaborator

Trials

1

Recruited

17,500+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Jacaranda Health

Collaborator

Trials

4

Recruited

32,800+

Published Research Related to This Trial

The BUMP trial is developing self-monitoring interventions for pregnant women to help detect high blood pressure early, which is crucial for preventing complications like pre-eclampsia.

Through qualitative research, the study identified key challenges women face in adhering to self-monitoring, leading to tailored strategies that enhance engagement and explain the benefits of monitoring, ultimately aiming to improve maternal and fetal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy. Band, R., Hinton, L., Tucker, KL., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06744231

Study Details | NCT06744231 | Thriving Hearts: Healing- ... The team hypothesizes that Thriving Hearts will reduce HDP incidence by 20%, consistent with effect sizes reported for several subcomponents of the multilevel ...

2. pcori.org pcori.org/research-results/2023/effectiveness-community-based-maternity-care-intervention-reducing-incidence-hypertensive-disorder-pregnancy

Effectiveness of a Community-Based Maternity Care ... This study tests the clinical effectiveness of a community-based maternity care intervention in reducing the incidence of hypertensive ...

3. withpower.com withpower.com/trial/phase-hypertension-2025-9f0ba

Thriving Hearts Program for High Blood Pressure During ... The Thriving Hearts treatment is unique because it focuses on lifestyle interventions, such as diet and physical activity, to manage high blood pressure during ...

4. pennmedicine.org pennmedicine.org/news/driving-down-postpartum-high-blood-pressure

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.

5. nhlbi.nih.gov nhlbi.nih.gov/news/2022/treating-chronic-hypertension-during-pregnancy-appears-safe-and-effective

Treating chronic hypertension during pregnancy appears safe ... Study shows treating mild preexisting high blood pressure during pregnancy improves outcomes for parents and babies external link. April 08 ...

6. newsobserver.com newsobserver.com/news/local/article282410783.html

NC study looks to reduce health disparities during pregnancy The North Carolina-based research, named the Thriving Hearts study, will specifically target disorders related to high blood pressure, called ...

7. saferbirth.org saferbirth.org/psbs/severe-hypertension-in-pregnancy/

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, ...