Telehealth for High Blood Pressure in Pregnancy

Overseen By Aderonke Adeniyi, MD, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Antihypertensives

Disqualifiers: Cardiac disorders, Substance abuse, Multifetal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Until the end of pregnancy week 31

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to compare the management of chronic hypertension during pregnancy using telehealth visits with blood pressure telemonitoring and health coaching as compared to standard in person clinic visits. The study involves pregnant woman aged 18-45 who are receiving care for chronic hypertension. Participation in this research study will last until their baby is delivered. The number of in-person clinic visits depends on the participant's treatment assignment. Those assigned to telehealth visits will have telehealth visits alternating with clinic visits every two weeks until the end of pregnancy week 31. Those assigned to telehealth visits will also have five sessions with a health coach via telephone or video from the time of enrollment until the end of pregnancy week 36.

Who Is on the Research Team?

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

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?

Group I: Telehealth Cycle Experimental Treatment 2 Interventions

Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring.

Group II: Standard of Care Active Control 1 Intervention

In person clinic visits

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+