Remote Monitoring and Education for Postpartum Hypertension

Overseen By Salima Qamruddin, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ochsner Health System

Disqualifiers: Chronic hypertension, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

296 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that your blood pressure medications may be adjusted after delivery.

What data supports the effectiveness of the treatment Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education?

Research shows that remote blood pressure monitoring for postpartum hypertension is feasible and acceptable, leading to better blood pressure control and reduced health disparities. Studies indicate that women using remote monitoring have improved blood pressure outcomes compared to those receiving usual care. ^{1 2 3 4 5}

Is remote monitoring for postpartum hypertension safe for humans?

Remote monitoring for postpartum hypertension is generally considered safe and acceptable, with high levels of satisfaction reported among participants. It has been shown to improve care compliance and reduce disparities in follow-up care without posing an undue burden. ^{3 5 6 7 8}

How is the treatment for postpartum hypertension using remote monitoring and education different from other treatments?

This treatment is unique because it uses remote monitoring technology to track blood pressure at home, combined with cardiovascular education, which can improve follow-up care and reduce disparities in treatment access, especially for those in remote areas. Unlike traditional in-person visits, this approach offers convenience and has shown promise in improving blood pressure control and patient satisfaction. ^{1 2 3 4 5}

What is the purpose of 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 is for individuals who have experienced high blood pressure conditions during pregnancy, such as eclampsia or pre-eclampsia. Participants will engage in a program involving education and regular monitoring of their blood pressure after giving birth.

Inclusion Criteria

Postpartum status

Experience new-onset hypertension during pregnancy

Enrollment in Connected MOM

Exclusion Criteria

History of preeclampsia or gestational hypertension during previous pregnancy

I have a long-term high blood pressure problem.

I have kidney problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive education and remote blood pressure monitoring with medication adjustments for 6 weeks postpartum

6 weeks

Televisits for medication adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of ED visits and re-admissions

1 year

Treatment Details

Interventions

• Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

Trial Overview The study tests whether educational videos on hypertension during pregnancy (HDP), daily text reminders, and telehealth follow-ups can help manage postpartum hypertension. It also looks at the impact on emergency visits, hospital readmissions, and other adverse outcomes.

Participant Groups

Group I: Intervention Experimental Treatment 3 Interventions

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

Group II: Control Active Control 1 Intervention

This group will receive usual post partum care from their obstetrician

Who Is Running the Clinical Trial?

Ochsner Health System

Lead Sponsor

Trials

97

Recruited

91,900+

Findings from Research

Hypertensive disorders of pregnancy are a major cause of maternal morbidity and mortality, particularly in the postpartum period, highlighting the need for effective monitoring and care during this time.

Implementing remote blood pressure monitoring programs can improve care for postpartum patients, enhance blood pressure control, and reduce racial disparities in healthcare access, while being well-received by both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum remote home blood pressure monitoring: the new frontier. Corlin, T., Raghuraman, N., Rampersad, RM., et al.[2023]

This randomized controlled trial involving 186 women with postpartum hypertension demonstrated that self-management, which included daily blood pressure monitoring and telemonitoring for medication adjustments, was feasible and led to better blood pressure control compared to usual care.

The intervention group showed significantly lower blood pressure, particularly diastolic pressure, at 6 weeks and maintained better control up to 6 months, suggesting that self-management could be an effective strategy for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Cairns, AE., Tucker, KL., Leeson, P., et al.[2021]

Telehealth has emerged as a valuable tool for postpartum care, particularly for managing hypertension, with evidence suggesting it improves compliance and reduces disparities in follow-up care.

Remote blood pressure monitoring is feasible and acceptable for postpartum women, making it a promising strategy for enhancing maternal health outcomes during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing Better Evidence on Remote Monitoring for Postpartum Hypertension: A Silver Lining of the Coronavirus Pandemic. Sawyer, MR., Jaffe, EF., Naqvi, M., et al.[2020]

The MyWellSpan mobile application was found to be a feasible method for postpartum women who experienced preeclampsia to self-monitor their blood pressure, with 69% of participants submitting at least one measurement.

Participants reported high satisfaction with the ease of use of the blood pressure cuff and the monitoring process, indicating that mobile health applications could effectively engage this population in their postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Using Blood Pressure Self-Monitoring and the Epic MyChart Blood Pressure Flowsheet to Monitor Blood Pressure After Preeclampsia. Burgess, A., Gartrell, K., Anderson, T.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Postpartum Remote Hypertension Monitoring Protocol Implemented at the Hospital Level. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Postpartum remote home blood pressure monitoring: the new frontier. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Establishing Better Evidence on Remote Monitoring for Postpartum Hypertension: A Silver Lining of the Coronavirus Pandemic. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Association of a Remote Blood Pressure Monitoring Program With Postpartum Adverse Outcomes. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Using Blood Pressure Self-Monitoring and the Epic MyChart Blood Pressure Flowsheet to Monitor Blood Pressure After Preeclampsia. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial. [2023]