Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

Not Applicable

Recruiting

• Conditions: Pre-Eclampsia; Complicating Pregnancy; Gestational Hypertension

• Registration Number: NCT06920563
• Lead Sponsor: Ochsner Health System

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-17
• Study First Submitted: 2025-03-25
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-10-16
• Study Completion: 2026-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ochsner Baptist; 🇺🇸 New Orleans, Louisiana, United States