Clinical trial NCT06920563: Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Eclampsia; Complicating Pregnancy
Gestational Hypertension
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 296
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Engagement
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
measure: Duration of Participation
timeFrame: 6 weeks
Secondary outcomes:
measure: Post partum Blood pressure
timeFrame: 1 year
measure: Number of ED visits
timeFrame: 1 year
measure: Severe Maternal Morbidity
timeFrame: 1 year
measure: Number of Inpatient re-admissions
timeFrame: 1 year
measure: Post partum visit follow up
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Baptist
state: Louisiana
Study officials:
References:
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