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Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05826925
Enrollment
30
Registered
2023-04-24
Start date
2026-07-15
Completion date
2027-08-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Hypertension Complicating Pregnancy, Hypertension, Pregnancy Induced, Patient Engagement, Preeclampsia

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.

Detailed description

Current evidence demonstrates that women with hypertensive disorders of pregnancy have 2-fold higher risk for the later development of cardiovascular disease (CVD) compared to women with healthy pregnancies. CVD prevention is a high priority for women's health, as it is the leading cause of death among women in the United States. In order to improve women's cardiovascular health, interventions for cardiovascular prevention could be initiated shortly after a pregnancy complicated by a hypertensive disorder. However, patient-centered interventions to promote preventive care engagement among postpartum women are lacking. Our objective is to address current gaps in knowledge regarding needs, values, and barriers regarding cardiovascular prevention among postpartum women with hypertensive disorders of pregnancy, and to remedy the lack of available evidence-based interventions for this at-risk population. To this end, we will conduct a pilot study to demonstrate feasibility and preliminary efficacy of a patient decision aid to improve patient knowledge and self-efficacy regarding CVD prevention during the postpartum period

Interventions

OTHERDecision 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.

Sponsors

University of Utah
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Decisional conflict6-8 weeks postpartumMeasured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

Secondary

MeasureTime frameDescription
Decisional conflictOne month after the initial assessmentMeasured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

Countries

United States

Contacts

CONTACTLauren Theilen, MD
lauren.theilen@hsc.utah.edu801-581-8425

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026