Decision Aid for Hypertensive Disorders of Pregnancy

Overseen By Lauren Theilen, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Cardiovascular disease, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new tool designed to help women who experienced high blood pressure during pregnancy engage in heart health care after giving birth. The goal is to determine if this decision aid can reduce their risk of heart disease later. Participants will either use this decision aid or follow regular postpartum care. Women who recently gave birth at the University of Utah and had high blood pressure during pregnancy might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance postpartum heart health care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision aid is safe for postpartum women?

Research has shown that decision aids are generally safe to use. These tools help people make informed health choices by providing clear and useful information. They support decision-making rather than treat conditions, so they don't carry the same risks as medications or surgeries.

In past studies, decision aids have been used for various health issues without causing harm. They empower people to take more control over their health decisions. Since this trial focuses on a decision aid for new mothers after childbirth, safety concerns are minimal. No reports of problems have emerged from using decision aids in similar situations.

Overall, the decision aid in this study is expected to be safe and helpful, allowing new mothers to understand their heart health options without any safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the decision aid for hypertensive disorders of pregnancy because it offers a new way to support postpartum women in making informed health decisions. Unlike standard care, which primarily involves routine monitoring and medications, this tool empowers women by providing personalized information and options tailored to their unique health situation. This approach aims to enhance patient engagement and satisfaction, potentially leading to better health outcomes.

What evidence suggests that this decision aid is effective for hypertensive disorders of pregnancy?

Research has shown that decision-making tools after childbirth, especially for those with high blood pressure during pregnancy, can improve health outcomes. In this trial, one group of participants will use a decision aid during the postpartum period, while another group will receive usual care. One study found that remote health monitoring, a type of decision tool, led to fewer hospital visits and improved adherence to medical advice. High blood pressure during pregnancy raises the risk of heart disease later, making early care crucial. Although more research is needed, these early findings suggest that decision tools can enhance health management after pregnancy. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking women who recently gave birth at the University of Utah and had high blood pressure issues during pregnancy. It's not open to those with a history of cardiovascular diseases like heart attack or stroke, or cognitive/vision impairments that would prevent understanding the study materials.

Inclusion Criteria

Written informed consent obtained

I can speak and read English or Spanish.

You recently had a pregnancy with high blood pressure complications at the University of Utah during your current hospital stay.

Exclusion Criteria

I have a history of heart or blood vessel disease.

You have trouble thinking clearly or seeing well, which makes it hard for you to talk or understand information.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a decision aid to improve knowledge and self-efficacy regarding cardiovascular disease prevention during the postpartum period

6-8 weeks

Postpartum visits as per standard care

Follow-up

Participants are monitored for decisional conflict and engagement in cardiovascular preventive care

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decision aid

Trial Overview The study is testing a decision aid designed to help these new mothers engage in preventive care against heart disease. Since they're at higher risk after having high blood pressure complications in pregnancy, this tool aims to guide them towards better heart health.

How Is the Trial Designed?

Group I: Decision aid Experimental Treatment 1 Intervention

Participants will use the decision aid in the postpartum period

Group II: Usual care Active Control 1 Intervention

Participants will receive standard postpartum care

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11326966/

Clinical Outcomes Associated With a Remote Postpartum ... Remote monitoring of postpartum hypertension was associated with fewer readmissions, increased adherence to national clinical guidelines, and ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Hypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization.

3. nature.com nature.com/articles/s44294-025-00095-7

Advances in postpartum hypertension management The increased cardiovascular risk associated with hypertensive disorders of pregnancy (HDP) necessitates methods to improve cardiometabolic ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK592551/

Management of Postpartum Hypertensive Disorders of ... - NCBI There is insufficient evidence to conclude that HBPM reduces severe maternal morbidity or mortality or reduces racial disparities in clinical outcomes.

5. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/related_files/hypertensive-disorders-pregnancy-disposition-comments.pdf

Management of Postpartum Hypertensive Disorders of ... Management of Postpartum Hypertensive Disorders of Pregnancy. Comparative Effectiveness Review No. 263. (Prepared by the Brown. Evidence-based Practice Center ...

6. 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, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11982344/

Postpartum management of hypertensive disorders of ... Globally, HDP is the second leading cause of maternal mortality, behind maternal hemorrhage.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2210778925000807

Implementation of a novel surveillance and clinical ... Hypertensive disorders contribute significantly to maternal morbidity and mortality. We sought to evaluate the impact of a clinical decision-support (CDS) ...