Preeclampsia Clinical Trial
— PrEPSOfficial 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.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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MemorialCare Health System |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preeclampsia knowledge score - short | Short term preeclampsia knowledge score | Measured at 24 hours postpartum | |
Secondary | Preeclampsia knowledge score - long | Long term preeclampsia knowledge score | Measured between 4 - 6 weeks postpartum | |
Secondary | GAD-7 score | Generalized anxiety score | Measured between 4-6 weeks postpartum | |
Secondary | 72 hour BP check | Adherence to a blood pressure check | Measured 72 hours after hospital discharge | |
Secondary | Postpartum visit | Adherence to one postpartum visit | Measured within 6 weeks postpartum | |
Secondary | Daily BP recordings | Percent of daily blood pressure recordings at home | Measured within 6 weeks postpartum | |
Secondary | Accessed material | Number of times information accessed postpartum | Measured at 6 weeks postpartum | |
Secondary | Unplanned readmission | Number of unplanned readmissions related to preeclampsia | Measured at 6 weeks postpartum |
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