Hypertension, Pregnancy InducedNCT05826925
Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
A study testing Decision aid in people with Hypertension, Pregnancy Induced and Hypertension Complicating Pregnancy, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pregnancy Induced, Hypertension Complicating Pregnancy, Preeclampsia
- What is being tested?
- Decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Lauren Theilen, MD, 801-581-8425, lauren.theilen@hsc.utah.edu
About this study
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.
Read the 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
- Conditions
- Hypertension, Pregnancy Induced, Hypertension Complicating Pregnancy, Preeclampsia, Cardiovascular Diseases, Patient Engagement
- Being tested
- Decision aid
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, Cardiovascular Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Experimental | Participants will use the decision aid in the postpartum period Receives: Other: Decision aid |
| Usual care | No intervention | Participants will receive standard postpartum care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Measured: 6-8 weeks postpartum
Secondary outcomes (1)
Decisional conflict
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Measured: One month after the initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 Jul 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Pregnancy InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Lauren Theilen, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826925
- Sponsor's protocol ID
- 00151518
- Other IDs
- K23HL159316
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT05826925
- Acronym / sponsor ID
- 00151518
- Conditions
- Hypertension, Pregnancy Induced, Hypertension Complicating Pregnancy, Preeclampsia, Cardiovascular Diseases, Patient Engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Experimental | Other: Decision aidParticipants will use the decision aid in the postpartum period |
| Usual care | No intervention | –Participants will receive standard postpartum care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidA 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. | Other | Decision aid |
Primary outcome
Decisional conflict
Time frame: 6-8 weeks postpartum
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
1 secondary outcome
Decisional conflict
Time frame: One month after the initial assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Hypertension, Pregnancy Induced and Hypertension Complicating Pregnancy, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Theilen, MD (801-581-8425, lauren.theilen@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: 6-8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.