Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

NCT06920563 | Recruiting

• 1 other identifier: 2023.192
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pre-Eclampsia; Complicating Pregnancy; Gestational Hypertension

Outcome Measures

Primary Outcomes (3)

• Engagement

  Engagement will be defined by frequency of use: number of remote BP measurements ascertained during the 6 week postpartum period.

  6 weeks

• Acceptability

  Post program survey questions using 5-item Likert response scale at 6 weeks postpartum

  6 weeks

• Duration of Participation

  Duration of participation is defined by the last day of recorded remote BP measurement

  6 weeks

Secondary Outcomes (5)

• Post partum Blood pressure

  1 year

• Number of ED visits

  1 year

• Severe Maternal Morbidity

  1 year

• Number of Inpatient re-admissions

  1 year

• Post partum visit follow up

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

This group will watch an education video, receive text message updates, and have their blood pressure medications titrated to a lower BP goal.

Other: Video; Other: Text Reminder; Other: Blood pressure threshold

Control

NO INTERVENTION

This group will receive usual post partum care from their obstetrician

Interventions

Video OTHER

Those in the intervention arm will watch a short educational video.

Intervention

Text Reminder OTHER

Those in the intervention group will receive regular text message reminders to check their blood pressures

Intervention

Blood pressure threshold OTHER

Those in the intervention group will have a lower blood pressure threshold to titrate their BP medications towards

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Baptist

New Orleans, Louisiana, 70115, United States

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bushnell C, Chireau M. Preeclampsia and Stroke: Risks during and after Pregnancy. Stroke Res Treat. 2011 Jan 20;2011:858134. doi: 10.4061/2011/858134.

  PMID: 21331165 BACKGROUND

• Benschop L, Duvekot JJ, Versmissen J, van Broekhoven V, Steegers EAP, Roeters van Lennep JE. Blood Pressure Profile 1 Year After Severe Preeclampsia. Hypertension. 2018 Mar;71(3):491-498. doi: 10.1161/HYPERTENSIONAHA.117.10338.

  PMID: 29437895 BACKGROUND

• Honigberg MC, Zekavat SM, Aragam K, Klarin D, Bhatt DL, Scott NS, Peloso GM, Natarajan P. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019 Dec 3;74(22):2743-2754. doi: 10.1016/j.jacc.2019.09.052. Epub 2019 Nov 11.

  PMID: 31727424 BACKGROUND

• Haug EB, Horn J, Markovitz AR, Fraser A, Klykken B, Dalen H, Vatten LJ, Romundstad PR, Rich-Edwards JW, Asvold BO. Association of Conventional Cardiovascular Risk Factors With Cardiovascular Disease After Hypertensive Disorders of Pregnancy: Analysis of the Nord-Trondelag Health Study. JAMA Cardiol. 2019 Jul 1;4(7):628-635. doi: 10.1001/jamacardio.2019.1746.

  PMID: 31188397 BACKGROUND

• Wu P, Haththotuwa R, Kwok CS, Babu A, Kotronias RA, Rushton C, Zaman A, Fryer AA, Kadam U, Chew-Graham CA, Mamas MA. Preeclampsia and Future Cardiovascular Health: A Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003497. doi: 10.1161/CIRCOUTCOMES.116.003497. Epub 2017 Feb 22.

  PMID: 28228456 BACKGROUND

• Fasanya HO, Hsiao CJ, Armstrong-Sylvester KR, Beal SG. A Critical Review on the Use of Race in Understanding Racial Disparities in Preeclampsia. J Appl Lab Med. 2021 Jan 12;6(1):247-256. doi: 10.1093/jalm/jfaa149.

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• Ouyang P, Sharma G. The Potential for Pregnancy Heart Teams to Reduce Maternal Mortality in Women With Cardiovascular Disease. J Am Coll Cardiol. 2020 Nov 3;76(18):2114-2116. doi: 10.1016/j.jacc.2020.09.007. No abstract available.

  PMID: 33121719 BACKGROUND

• Gad MM, Elgendy IY, Mahmoud AN, Saad AM, Isogai T, Sande Mathias I, Misbah Rameez R, Chahine J, Jneid H, Kapadia SR. Disparities in Cardiovascular Disease Outcomes Among Pregnant and Post-Partum Women. J Am Heart Assoc. 2021 Jan 5;10(1):e017832. doi: 10.1161/JAHA.120.017832. Epub 2020 Dec 16.

  PMID: 33322915 BACKGROUND

• Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276.

  PMID: 30920918 BACKGROUND

• Croke L. Gestational Hypertension and Preeclampsia: A Practice Bulletin from ACOG. Am Fam Physician. 2019 Nov 15;100(10):649-650. No abstract available.

  PMID: 31730305 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Central Study Contacts

Salima Qamruddin, MD

CONTACT

+1 (504) 842-4135; salima.qamruddin@ochsner.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 9, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)