Preeclampsia Educational Program Study (PrEPS) (PrEPS)

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: Active, not recruiting
• Conditions: Preeclampsia; Preeclampsia Postpartum; Preeclampsia Severe; Preeclampsia Mild
• Intervention / Treatment: Other: Illustration based application; Other: Text based application

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: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Preeclampsia knowledge score - short	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

Outcome Measure	Measure Description	Time Frame
72 hour BP check	Adherence to a blood pressure check	Measured 72 hours after hospital discharge
Daily BP recordings	Percent of daily blood pressure recordings at home	Measured within 6 weeks postpartum
Accessed material	Number of times information accessed postpartum	Measured at 6 weeks postpartum
Unplanned readmission	Number of unplanned readmissions related to preeclampsia	Measured at 6 weeks postpartum
Preeclampsia knowledge score - long	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	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	Adherence to one postpartum visit	Measured within 6 weeks postpartum

Collaborators and Investigators

• Sponsor: MemorialCare Health System
• Investigators: Principal Investigator: Megan Oakes, MD MSCI, Magella Medical Group, MemorialCare

Publications and helpful links

General Publications

• You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.
• You WB, Wolf M, Bailey SC, Pandit AU, Waite KR, Sobel RM, Grobman W. Factors associated with patient understanding of preeclampsia. Hypertens Pregnancy. 2012;31(3):341-9. doi: 10.3109/10641955.2010.507851. Epub 2010 Sep 22.
• Collier AY, Molina RL. Maternal Mortality in the United States: Updates on Trends, Causes, and Solutions. Neoreviews. 2019 Oct;20(10):e561-e574. doi: 10.1542/neo.20-10-e561.
• Chames MC, Livingston JC, Ivester TS, Barton JR, Sibai BM. Late postpartum eclampsia: a preventable disease? Am J Obstet Gynecol. 2002 Jun;186(6):1174-7. doi: 10.1067/mob.2002.123824.
• Ditisheim A, Wuerzner G, Ponte B, Vial Y, Irion O, Burnier M, Boulvain M, Pechere-Bertschi A. Prevalence of Hypertensive Phenotypes After Preeclampsia: A Prospective Cohort Study. Hypertension. 2018 Jan;71(1):103-109. doi: 10.1161/HYPERTENSIONAHA.117.09799. Epub 2017 Nov 13.
• Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
• Dol J, Hughes B, Bonet M, Dorey R, Dorling J, Grant A, Langlois EV, Monaghan J, Ollivier R, Parker R, Roos N, Scott H, Shin HD, Curran J. Timing of maternal mortality and severe morbidity during the postpartum period: a systematic review. JBI Evid Synth. 2022 Sep 1;20(9):2119-2194. doi: 10.11124/JBIES-20-00578.
• Shree R, Hatfield-Timajchy K, Brewer A, Tsigas E, Vidler M. Information needs and experiences from pregnancies complicated by hypertensive disorders: a qualitative analysis of narrative responses. BMC Pregnancy Childbirth. 2021 Nov 2;21(1):743. doi: 10.1186/s12884-021-04219-0.
• Igdoura SA, Herscovics A, Lal A, Moremen KW, Morales CR, Hermo L. Alpha-mannosidases involved in N-glycan processing show cell specificity and distinct subcompartmentalization within the Golgi apparatus of cells in the testis and epididymis. Eur J Cell Biol. 1999 Jul;78(7):441-52. doi: 10.1016/s0171-9335(99)80071-5.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: education; preeclampsia
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID 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