Preeclampsia Educational Program Study (PrEPS) (PrEPS)

October 7, 2025 updated by: Megan Oakes, MemorialCare Health System

Preeclampsia Educational Program Study

Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Preeclampsia complicates approximately 8% of all pregnancies. While many patients improve following delivery, the disease process remains a leading cause for postpartum morbidity and mortality. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. There is a gap in the literature regarding effective, patient-centered educational tools specifically addressing these elements, especially in the postpartum period.

The investigators propose a pilot, randomized controlled trial of postpartum patients with preeclampsia. The intervention of interest is an illustration-based, educational mobile device application (app) focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum. The control for this study will be the same information in a text-only format, also accessed through a mobile device app.

The investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material.

Specific Aim 1: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention (short-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Specific Aim 2: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education >4 weeks post intervention (long-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at > 4 weeks post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • MemorialCare Long Beach Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preeclampsia with or without severe features
  • Able to read and speak English
  • Consistent access to mobile device with QR-reading capability and ability to access mobile-device application.
  • Pre-and postnatal care provided by OB Clinic (resident clinic) or Magella (maternal-fetal medicine)

Exclusion Criteria:

  • Patient age < 18 years old
  • Non-English speaking
  • Current enrollment in another trial targeting postpartum preeclampsia parameters
  • Arm width >40cm (XL Cuff)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Illustration
This study arm will receive education via an illustration based application
Other: Illustration based application
Illustrations regarding the cause, risks, and warning signs of preeclampsia
Active Comparator: Text
This study arm will receive education via text based application
Other: Text based application
Standard preeclampsia discharge instructions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preeclampsia knowledge score - short
Time Frame: Measured at 24 hours postpartum
Short term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment
Measured at 24 hours postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
72 hour BP check
Time Frame: Measured 72 hours after hospital discharge
Adherence to a blood pressure check
Measured 72 hours after hospital discharge
Daily BP recordings
Time Frame: Measured within 6 weeks postpartum
Percent of daily blood pressure recordings at home
Measured within 6 weeks postpartum
Accessed material
Time Frame: Measured at 6 weeks postpartum
Number of times information accessed postpartum
Measured at 6 weeks postpartum
Unplanned readmission
Time Frame: Measured at 6 weeks postpartum
Number of unplanned readmissions related to preeclampsia
Measured at 6 weeks postpartum
Preeclampsia knowledge score - long
Time Frame: Measured between 4 - 6 weeks postpartum
Long term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment
Measured between 4 - 6 weeks postpartum
GAD-7 score
Time Frame: Measured between 4-6 weeks postpartum
Generalized anxiety score. A score of 0-4 demonstrating none or minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety
Measured between 4-6 weeks postpartum
Number of participants who attend a postpartum visit
Time Frame: Measured within 6 weeks postpartum
Adherence to one postpartum visit
Measured within 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MemorialCare Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan Oakes, MD MSCI, Magella Medical Group, MemorialCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 461-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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