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Recruiting NCT06920563

Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

No phase Interventional Pre-Eclampsia; Complicating Pregnancy Gestational Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video, Text Reminder, Blood pressure threshold.
Who it may be relevant to
Registry conditions: Pre-Eclampsia; Complicating Pregnancy, Gestational Hypertension. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Engagement [Time frame: 6 weeks]
  • Acceptability [Time frame: 6 weeks]
  • Duration of Participation [Time frame: 6 weeks]
Secondary outcome measures (5)
  • Post partum Blood pressure [Time frame: 1 year]
  • Number of ED visits [Time frame: 1 year]
  • Severe Maternal Morbidity [Time frame: 1 year]
  • Number of Inpatient re-admissions [Time frame: 1 year]
  • Post partum visit follow up [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Ochsner Baptist — New Orleans

Publications

  • 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

Identifiers

NCT: NCT06920563 · 2023.192

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗