Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

Официальное название

Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education to Reduce Emergency Department Visits, Re-admissions and Adverse Cardiovascular Outcomes in Hypertensive Disorder of Pregnancy

Обзор

The goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. The main questions it aims to answer are: Is a structured postpartum remote blood pressure monitoring intervention with education and individualized medication initiation/adjustment follow-up by televisit feasible? Does a structured program reduce the occurrence of postpartum hypertension, ED visits, hospital readmissions, and adverse outcomes? Participants will: View an educational video on HDP post-delivery Receive 1-2 times daily text messages for 6 weeks postpartum Have their blood pressure medications adjusted to lower targets post partum

Вмешательства

• Другое Video
  Those in the intervention arm will watch a short educational video.
• Другое Text Reminder
  Those in the intervention group will receive regular text message reminders to check their blood pressures
• Другое Blood pressure threshold
  Those in the intervention group will have a lower blood pressure threshold to titrate their BP medications towards

Первичные конечные точки

• Engagement [Срок оценки: 6 weeks]
• Acceptability [Срок оценки: 6 weeks]
• Duration of Participation [Срок оценки: 6 weeks]

Вторичные конечные точки (5)

• Post partum Blood pressure [Срок оценки: 1 year]
• Number of ED visits [Срок оценки: 1 year]
• Severe Maternal Morbidity [Срок оценки: 1 year]
• Number of Inpatient re-admissions [Срок оценки: 1 year]
• Post partum visit follow up [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Age of at least 18 years.
• Postpartum status.
• Experience new-onset hypertension during pregnancy.
• Enrollment in Connected MOM.
• Ability to provide informed consent.
• Establish medical care within the Ochsner System to facilitate data collection.

Критерии исключения

• History of preeclampsia or gestational hypertension during previous pregnancy
• History of chronic hypertension
• History of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection)
• History of ischemic CVA
• History of Congestive heart failure
• Renal dysfunction
• Liver dysfunction
• Left ventricular dysfunction
• Congenital heart disease
• Still birth at delivery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ochsner Baptist — New Orleans

Публикации

• Mitro SD, Hedderson M, Xu F, Forquer H, Baker JM, Kuzniewicz MW, Greenberg M. Risk of postpartum readmission after hypertensive disorder of pregnancy and variation by discharge antihypertensive medication prescription. Am J Obstet Gynecol. 2024 Oct;231(4):456.e1-456.e13. doi: 10.1016/j.ajog.2024.01.015. Epub 2024 Jan 25. PMID 38280432
• SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. PMID 26551272
• Cairns AE, Tucker KL, Leeson P, Mackillop LH, Santos M, Velardo C, Salvi D, Mort S, Mollison J, Tarassenko L, McManus RJ; SNAP-HT Investigators. Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Hypertension. 2018 Aug;72(2):425-432. doi: 10.1161/HYPERTENSIONAHA.118.10911. Epub 2018 Jul 2. PMID 29967037
• Kitt JA, Fox RL, Cairns AE, Mollison J, Burchert HH, Kenworthy Y, McCourt A, Suriano K, Lewandowski AJ, Mackillop L, Tucker KL, McManus RJ, Leeson P. Short-Term Postpartum Blood Pressure Self-Management and Long-Term Blood Pressure Control: A Randomized Controlled Trial. Hypertension. 2021 Aug;78(2):469-479. doi: 10.1161/HYPERTENSIONAHA.120.17101. Epub 2021 Jun 28. PMID 34176288
• Hauspurg A, Lemon LS, Quinn BA, Binstock A, Larkin J, Beigi RH, Watson AR, Simhan HN. A Postpartum Remote Hypertension Monitoring Protocol Implemented at the Hospital Level. Obstet Gynecol. 2019 Oct;134(4):685-691. doi: 10.1097/AOG.0000000000003479. PMID 31503166
• Mujic E, Parker SE, Nelson KP, O'Brien M, Chestnut IA, Abrams J, Yarrington CD. Implementation of a Cell-Enabled Remote Blood Pressure Monitoring Program During the Postpartum Period at a Safety-Net Hospital. J Am Heart Assoc. 2024 Jul 2;13(13):e034031. doi: 10.1161/JAHA.123.034031. Epub 2024 Jun 27. PMID 38934890
• Bateman BT, Schumacher HC, Bushnell CD, Pile-Spellman J, Simpson LL, Sacco RL, Berman MF. Intracerebral hemorrhage in pregnancy: frequency, risk factors, and outcome. Neurology. 2006 Aug 8;67(3):424-9. doi: 10.1212/01.wnl.0000228277.84760.a2. PMID 16894102
• Jeng JS, Tang SC, Yip PK. Stroke in women of reproductive age: comparison between stroke related and unrelated to pregnancy. J Neurol Sci. 2004 Jun 15;221(1-2):25-9. doi: 10.1016/j.jns.2004.03.006. PMID 15178209

Идентификаторы

NCT: NCT06920563 · 2023.192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗