Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
June 25, 2025
June 1, 2025
2.4 years
April 10, 2023
June 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Decisional conflict
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
6-8 weeks postpartum
Secondary Outcomes (1)
Decisional conflict
One month after the initial assessment
Study Arms (2)
Decision aid
EXPERIMENTALParticipants will use the decision aid in the postpartum period
Usual care
NO INTERVENTIONParticipants will receive standard postpartum care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Obstetrics & Gynecology
Study Record Dates
First Submitted
April 10, 2023
First Posted
April 24, 2023
Study Start
February 27, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share