Health TrialsbyHealthPanel

Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

ConditionsPre-Eclampsia; Complicating PregnancyGestational Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOchsner Health System

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age of at least 18 years.

Postpartum status.

Experience new-onset hypertension during pregnancy.

Enrollment in Connected MOM.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Video

    Other intervention

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

  • Text Reminder

    Other intervention

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

  • Blood pressure threshold

    Other intervention

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

Treatment groups

296 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 3 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Engagement

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

Time frame
6 weeks
2

Acceptability

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

Time frame
6 weeks
3

Duration of Participation

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

Time frame
6 weeks

Secondary outcomes

1

Post partum Blood pressure

Proportion of patients with BP \<130/80 at 6 weeks Mean SBP, DBP at 6 weeks, 6 months, 1 year postpartum

Time frame
1 year
2

Number of ED visits

Number of ED visits recorded after discharge from her delivery encounter over the following year.

Time frame
1 year
3

Severe Maternal Morbidity

Incidence of death, postpartum stroke, congestive heart failure, myocardial infarction, eclampsia

Time frame
1 year
4

Number of Inpatient re-admissions

Number of inpatient re-admissions over the following year after discharge from delivery encounter

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ochsner Health System

Lead sponsor

Source ClinicalTrials.gov
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