PreeclampsiaPrEPSNCT06373367
Preeclampsia Educational Program Study (PrEPS)
A study testing Illustration based application and Text based application in people with Preeclampsia and Preeclampsia Severe, run by MemorialCare Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Preeclampsia Severe, Preeclampsia Mild
- What is being tested?
- Illustration based application and Text based application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 May 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patient age < 18 years old
- Non-English speaking
- Current enrollment in another trial targeting postpartum preeclampsia parameters
- Arm width >40cm (XL Cuff)
Trial locations and contacts
1 site in 1 country.
United States1 site
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
About this study
Official title: 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.
Read the 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.
- Being tested
- Illustration based application, Text based application
- Keywords
- preeclampsia, education
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illustration based applicationOther
Illustrations regarding the cause, risks, and warning signs of preeclampsia
Text based applicationOther
Standard preeclampsia discharge instructions
| Study group | Role | What they receive |
|---|---|---|
| Illustration | Experimental | This study arm will receive education via an illustration based application Receives: Other: Illustration based application |
| Text | Active comparator | This study arm will receive education via text based application Receives: Other: Text based application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia knowledge score - short
Short term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment
Measured: Measured at 24 hours postpartum
Secondary outcomes (7)
Preeclampsia knowledge score - long
Long term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment
Measured: 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: Measured between 4-6 weeks postpartum
72 hour BP check
Adherence to a blood pressure check
Measured: Measured 72 hours after hospital discharge
Number of participants who attend a postpartum visit
Adherence to one postpartum visit
Measured: Measured within 6 weeks postpartum
Daily BP recordings
Percent of daily blood pressure recordings at home
Measured: Measured within 6 weeks postpartum
Accessed material
Number of times information accessed postpartum
Measured: Measured at 6 weeks postpartum
Unplanned readmission
Number of unplanned readmissions related to preeclampsia
Measured: Measured at 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Oct 2024
- Primary completion29 May 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Oakes, MemorialCare Health System
- Investigators
- Megan Oakes, MD MSCI, Principal investigator, Magella Medical Group, MemorialCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373367
- Sponsor's protocol ID
- 461-24
- Acronym
- PrEPS
- Status last verified
- Oct 2025
- First submitted
- 15 Apr 2024
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruno AM, Allshouse AA, Metz TD, Theilen LH. Trends in Hypertensive Disorders of Pregnancy in the United States From 1989 to 2020. Obstet Gynecol. 2022 Jul 1;140(1):83-86. doi: 10.1097/AOG.0000000000004824. Epub 2022 Jun 7.
PubMed 35849460Dol 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.
PubMed 35916004Shree 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.
PubMed 34724906You 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.
PubMed 22542120You 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.
PubMed 20860492Chames 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.
PubMed 12066093Collier 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.
PubMed 31575778Ditisheim 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.
PubMed 29133363Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
PubMed 32443079
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia Educational Program Study
- ClinicalTrials.gov ID
- NCT06373367
- Acronym / sponsor ID
- PrEPS / 461-24
- Keywords
- preeclampsia, education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Apr 2024 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Illustration | Experimental | Other: Illustration based applicationThis study arm will receive education via an illustration based application |
| Text | Active comparator | Other: Text based applicationThis study arm will receive education via text based application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Patient age < 18 years old
- Non-English speaking
- Current enrollment in another trial targeting postpartum preeclampsia parameters
- Arm width >40cm (XL Cuff)
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 |
|---|---|---|
| Illustration based applicationIllustrations regarding the cause, risks, and warning signs of preeclampsia | Other | Illustration |
| Text based applicationStandard preeclampsia discharge instructions | Other | Text |
Primary outcome
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
7 secondary outcomes
Preeclampsia knowledge score - long
Time frame: Measured between 4 - 6 weeks postpartum
GAD-7 score
Time frame: Measured between 4-6 weeks postpartum
72 hour BP check
Time frame: Measured 72 hours after hospital discharge
Number of participants who attend a postpartum visit
Time frame: Measured within 6 weeks postpartum
Daily BP recordings
Time frame: Measured within 6 weeks postpartum
Accessed material
Time frame: Measured at 6 weeks postpartum
Unplanned readmission
Time frame: Measured at 6 weeks postpartum
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 9 Oct 2025.
- Background: PubMed 35849460Bruno AM, Allshouse AA, Metz TD, Theilen LH. Trends in Hypertensive Disorders of Pregnancy in the United States From 1989 to 2020. Obstet Gynecol. 2022 Jul 1;140(1):83-86. doi: 10.1097/AOG.0000000000004824. Epub 2022 Jun 7.
- Background: PubMed 35916004Dol 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.
- Background: PubMed 34724906Shree 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.
- Background: PubMed 22542120You 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.
- Background: PubMed 20860492You 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.
- Background: PubMed 12066093Chames 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.
- Background: PubMed 31575778Collier 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.
- Background: PubMed 29133363Ditisheim 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.
- Background: PubMed 32443079Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
- 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. This study is not recruiting at the moment.
Megan Oakes, MD MSCI principal investigator
Magella Medical Group, MemorialCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Illustration based application and Text based application in people with Preeclampsia and Preeclampsia Severe, run by MemorialCare Health System 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia knowledge score - short (time frame: Measured at 24 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06373367, which also lists 9 linked publications.
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 9 Oct 2025.