Recruiting

Cardiovascular Care

Sponsor:

University of Utah

Code:

NCT05826925

Conditions

Hypertension, Pregnancy Induced

Hypertension Complicating Pregnancy

Preeclampsia

Cardiovascular Diseases

Patient Engagement

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Decision aid

Study Details

Brief summary:

Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

Conditions

Hypertension, Pregnancy Induced

Hypertension Complicating Pregnancy

Preeclampsia

Cardiovascular Diseases

Patient Engagement

Study ID

NCT05826925

Start date

Jul 15, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Delivered a pregnancy complicated by a hypertensive disorder of pregnancy at the University of Utah during the current hospital admission
  • Ability to speak and read English or Spanish
  • Written informed consent obtained

Exclusion Criteria:

  • Cardiovascular disease diagnosis (history of peripheral artery disease, stroke, or myocardial infarction)
  • Impairment of cognitive function or vision that prohibits communication and/or reading the decision aid.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Decision aid

Participants will use the decision aid in the postpartum period

no intervention: Usual care

Participants will receive standard postpartum care

Interventions

Decision aid

A decision aid will be developed based on qualitative data from Aim 1 and iterative refinement with input from stakeholders from Aim 2. Anticipated content includes: 1) information about cardiovascular risk following hypertensive disorders of pregnancy; 2) goal-setting exercises for blood pressure, weight management, glucose control, physical activity, and smoking cessation; 3) self-care steps to achieve management targets; 4) values clarification exercises to identify values related to cardiovascular risk management and identify priority areas for focus and improvement; and 5) discussion of how to communicate questions and goals of treatment to their provider.

Primary outcome measure

  • Decisional conflict [ Time Frame: 6-8 weeks postpartum ]

Central Contacts and Locations

Central contacts

Lauren Theilen, MD

801-581-8425lauren.theilen@hsc.utah.edu

Locations

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Lauren Theilen, MD

801-581-8425lauren.theilen@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-06-23.