Telehealth for High Blood Pressure in Pregnancy

EO
AA
Overseen ByAderonke Adeniyi, MD, MS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether managing high blood pressure during pregnancy through telehealth visits and remote monitoring is as effective as regular in-person visits. Pregnant women with a history of chronic hypertension (high blood pressure before pregnancy) can participate. Participants alternate between telehealth and clinic visits, with additional support through health coaching for those in the telehealth group. The goal is to determine if remote care can offer the same benefits and convenience as traditional in-person care. As an unphased trial, this study allows participants to contribute to innovative research that could improve healthcare convenience and accessibility for pregnant women.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, since it involves managing chronic hypertension, you might continue your current antihypertensive medication. It's best to discuss this with the trial team.

What prior data suggests that telehealth and remote blood pressure monitoring is safe for managing high blood pressure in pregnancy?

Research has shown that checking blood pressure from home is safe for pregnant women, even those at high risk for high blood pressure. Studies indicate that telehealth monitoring encourages women to check their blood pressure more frequently, improving condition management.

In one large study, women checked their blood pressure 1.56 times more often after leaving the hospital when using remote monitoring. Another program found that remote monitoring helped more mothers track their blood pressure during and after pregnancy.

Although some women still experienced severe high blood pressure, remote monitoring was generally well-received. This evidence suggests that telehealth and remote monitoring provide a safe and effective way to manage high blood pressure during pregnancy.12345

Why are researchers excited about this trial?

Researchers are excited about using telehealth and remote blood pressure monitoring for managing high blood pressure in pregnancy because it offers a more flexible and accessible approach compared to traditional in-person clinic visits. This treatment allows pregnant women to monitor their blood pressure from the comfort of their homes, potentially reducing the need for frequent trips to the clinic. Additionally, telehealth provides continuous support and real-time adjustments to care, which can lead to better management of hypertension during pregnancy. This method could significantly improve convenience and healthcare outcomes for expectant mothers.

What evidence suggests that telehealth and remote blood pressure monitoring is effective for managing high blood pressure in pregnancy?

Research has shown that checking blood pressure at home can help manage high blood pressure in pregnant women. One study found that home monitoring increased the number of blood pressure checks by 1.56 times shortly after hospital discharge. Another study with 937 pregnant women demonstrated better blood pressure control and improved health through home monitoring. It also found that home monitoring detected high blood pressure more reliably across different groups. In this trial, participants in the "Telehealth Cycle" arm will receive telehealth visits along with blood pressure telemonitoring, which might effectively manage high blood pressure during pregnancy.13678

Who Is on the Research Team?

AO

Aderonke O Adeniyi, MD, MS

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-45 with chronic hypertension. Participants will be involved in the study until their baby's delivery, and must be receiving care for high blood pressure.

Inclusion Criteria

Pregnant women
I have been diagnosed with chronic hypertension.
I was diagnosed with high blood pressure or was on medication for it before pregnancy.

Exclusion Criteria

Any significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study
Current substance abuse disorder
Multifetal pregnancy
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth visits with remote blood pressure monitoring and health coaching, alternating with in-person clinic visits

Until the end of pregnancy week 31
Telehealth visits alternating with clinic visits every two weeks

Health Coaching

Participants receive five sessions with a health coach via telephone or video

Until the end of pregnancy week 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Telehealth and Remote Blood Pressure

Trial Overview

The study compares managing chronic hypertension during pregnancy through telehealth visits with remote blood pressure monitoring and health coaching versus standard in-person clinic visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth CycleExperimental Treatment2 Interventions
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Remote Blood Pressure Monitoring in Pregnancies at Risk ...

This review examines the literature on remote blood pressure monitoring (RBPM) for pregnant women at high risk of hypertensive disorders of pregnancy (HDP).

Obstetric Hypertension: The Largest Study in Remote ...

Post-hospital discharge remote blood pressure monitoring in pregnancy improved, with a 1.56-fold increase in measurements within the first 20 ...

Improving obstetric and perinatal outcomes with a remote ...

A remote HTN monitoring program for 937 obstetric patients was associated with improved BP monitoring, better postpartum BP control, and improved linkages to ...

Implementation of a Cell‐Enabled Remote Blood Pressure ...

A cell‐enabled postpartum remote BP monitoring program was successful in uniformly monitoring BP and capturing hypertension among a diverse, safety‐net ...

Remote Monitoring Compared With In-Office Surveillance ...

Remote monitoring can increase postpartum blood pressure ascertainment within 10 days of discharge for women with hypertensive disorders of pregnancy.

Postpartum remote home blood pressure monitoring

Remote monitoring programs have found that rates of severe hypertension occur in 12.8% to 26.2% of their participants, and between 42% and 65.1% of ...

App-based Remote Blood Pressure Monitoring

Remote postpartum blood pressure monitoring program with text messages has been shown to increase adherence to recommended postpartum blood pressure checks.

Technology Supports Maternal Health with Remote Blood ...

Our program data indicates this intervention is helping more mothers keep track of their blood pressure during pregnancy and after delivery, ...