Preeclampsia Educational Program Study (PrEPS)

NCT06373367 | Active Not Recruiting

• 1 other identifier: 461-24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia; Preeclampsia Severe; Preeclampsia Mild; Preeclampsia Postpartum

Keywords

preeclampsia; education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Preeclampsia knowledge score - long

  Measured between 4 - 6 weeks postpartum

• GAD-7 score

  Measured between 4-6 weeks postpartum

• 72 hour BP check

  Measured 72 hours after hospital discharge

• Number of participants who attend a postpartum visit

  Measured within 6 weeks postpartum

• Daily BP recordings

  Measured within 6 weeks postpartum

Study Arms (2)

Illustration

EXPERIMENTAL

This study arm will receive education via an illustration based application

Other: Illustration based application

Text

ACTIVE COMPARATOR

This study arm will receive education via text based application

Other: Text based application

Interventions

Illustration based application OTHER

Illustrations regarding the cause, risks, and warning signs of preeclampsia

Illustration

Text based application OTHER

Standard preeclampsia discharge instructions

Text

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States

Location

Related Publications (9)

• 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.

  PMID: 10472797 BACKGROUND

• 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.

  PMID: 35916004 BACKGROUND

• 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.

  PMID: 34724906 BACKGROUND

• 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.

  PMID: 22542120 BACKGROUND

• 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.

  PMID: 20860492 BACKGROUND

• 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.

  PMID: 12066093 BACKGROUND

• 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.

  PMID: 31575778 BACKGROUND

• 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.

  PMID: 29133363 BACKGROUND

• Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.

  PMID: 32443079 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Megan Oakes, MD MSCI

  Magella Medical Group, MemorialCare

  PRINCIPAL INVESTIGATOR

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: MD MCSI

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: October 1, 2024
• Primary Completion: May 29, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)