Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

April 1, 2025 updated by: Ochsner Health System

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Ochsner Baptist
        • Contact:
        • Contact:
          • Salima Qamruddin
        • Contact:
          • Frank Williams, MD
        • Contact:
          • Talia Suner, MD
        • Contact:
          • Koyenum Obi, MD
        • Contact:
          • Keira Barker, MD
        • Contact:
          • Daniel Morin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of preeclampsia or gestational hypertension during previous pregnancy
  2. History of chronic hypertension
  3. History of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection)
  4. History of ischemic CVA
  5. History of Congestive heart failure
  6. Renal dysfunction
  7. Liver dysfunction
  8. Left ventricular dysfunction
  9. Congenital heart disease
  10. Still birth at delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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
No Intervention: Control
This group will receive usual post partum care from their obstetrician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement
Time Frame: 6 weeks
Engagement will be defined by frequency of use: number of remote BP measurements ascertained during the 6 week postpartum period.
6 weeks
Acceptability
Time Frame: 6 weeks
Post program survey questions using 5-item Likert response scale at 6 weeks postpartum
6 weeks
Duration of Participation
Time Frame: 6 weeks
Duration of participation is defined by the last day of recorded remote BP measurement
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post partum Blood pressure
Time Frame: 1 year
Proportion of patients with BP <130/80 at 6 weeks Mean SBP, DBP at 6 weeks, 6 months, 1 year postpartum
1 year
Number of ED visits
Time Frame: 1 year
Number of ED visits recorded after discharge from her delivery encounter over the following year.
1 year
Severe Maternal Morbidity
Time Frame: 1 year
Incidence of death, postpartum stroke, congestive heart failure, myocardial infarction, eclampsia
1 year
Number of Inpatient re-admissions
Time Frame: 1 year
Number of inpatient re-admissions over the following year after discharge from delivery encounter
1 year
Post partum visit follow up
Time Frame: 6 weeks
Proportion of 4-6 week postpartum follow up visit attendance with OB provider
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

October 16, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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