ClinicalTrials.gg
RecruitingNCT05826925Updated Jun 23, 2026

Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

An interventional study of Decision aid in Hypertension, Pregnancy Induced, Hypertension Complicating Pregnancy and Preeclampsia, sponsored by University of Utah. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.

Primary conditionPre-EclampsiaRegistry: Hypertension, Pregnancy-InducedReclassifiedWhy we changed it
Registry
Hypertension, Pregnancy-Induced — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pre-Eclampsia
Why
  1. The study's listed conditions name Pre-Eclampsia, a narrower term within Hypertension, Pregnancy-Induced.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Utah · Not applicable, Interventional, and Other

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 228 studies in Pre-Eclampsia with a site in United States — 60 open to participants now, 76 under way, 6 of them phase 3. Pre-Eclampsia · United States.

Planned enrollment
116th of 159
30 · median 89
Started
2026
with 27 others
No phase
71 of 228
17 open now
Primary completion
2027-08
later than 43 of 75 live
Registered
163rd of 228
by date

Among the 228 studies in Pre-Eclampsia with a site in United States, this one is the 116th largest by planned enrollment of the 159 interventional ones that give a count, is one of 28 that started in 2026, is one of 71 with no phase, reaches primary completion later than 43 of the 75 other live ones, and was the 163rd registered.

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

Browse Pre-Eclampsia studies →

Open to participants now

60 of the 228 studies in Pre-Eclampsia with a site in United States are open now. Recruiting first, the newest first:

54 more — sign in →

All 60 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 228 studies in Pre-Eclampsia with a site in United States, or all of them as a file.
02

Study 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.

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

03

Conditions studied

  • Hypertension, Pregnancy Induced
  • Hypertension Complicating Pregnancy
  • Preeclampsia
  • Cardiovascular Diseases
  • Patient Engagement
04

In context

Pre-Eclampsia Reclassified

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 30 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

University of Utah is the lead sponsor of 996 studies on the registry; 177 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Compared within Pre-Eclampsia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Pregnancy-Induced. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 obtained

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Decision aid

    Participants will use the decision aid in the postpartum period

    Other: Decision aid

  • No intervention
    Usual care

    Participants will receive standard postpartum care

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.

07

What researchers measure

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)

    Time frame: 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)

    Time frame: One month after the initial assessment

08

Study locations

1 of 1 sites recruiting
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Aug 2027, 13 months later.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 13 months is below that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2023
First posted
Apr 24, 2023
StartEst.
Jul 15, 2026
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05826925
Lead sponsor
University of Utah
Responsible party
Lauren Theilen (Assistant Professor, Obstetrics & Gynecology, University of Utah) — Principal investigator
First posted
Apr 24, 2023
Start date
Jul 15, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Lauren Theilen, MD
Contact
lauren.theilen@hsc.utah.edu
801-581-8425

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion