Recruiting

Telehealth Management

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07356518

Conditions

Hypertension

Hypertension in Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Telehealth visits

In-person visits

Study Details

Brief summary:

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.

Conditions

Hypertension

Hypertension in Pregnancy

Study ID

NCT07356518

Start date

Apr 22, 2026

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • prior diagnosis of Chronic hypertension (cHTN)
  • Pregnant women
  • Known: documented diagnosis or on antihypertensive medication prior to pregnancy

Exclusion Criteria:

  • Any significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study
  • Cardiac disorders: cardiomyopathy, angina, Coronary Artery Disease (CAD)
  • Current substance abuse disorder
  • Multifetal pregnancy
  • Participation in another study without prior approval
  • Plan to deliver outside Atrium Health Wake Forest Baptist
  • Prior stroke
  • Severe hypertension
  • Suspected or known fetal major structural/chromosomal abnormality or fetal demise

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telehealth Cycle

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

active comparator: Standard of Care

In person clinic visits

Interventions

Telehealth visits

remote visits with participants

In-person visits

standard of care visits with care provider in person

Primary outcome measure

  • Feasibility of telehealth with remote BP telemonitoring compared to standard care [ Time Frame: Gestational Week 31 ]
  • Safety of telehealth combined with telemonitoring compared to standard care [ Time Frame: Gestational Week 31 ]

Central Contacts and Locations

Central contacts

Ejiro Obioma, MBBS MMCi

704-355-2000Ejiro.Obioma@Advocatehealth.org

Aderonke Adeniyi, MD, MS

337 713 2278aderonke.adeniyi@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Ejiro Obioma, MBBS MMCi

704-355-2000Ejiro.Obioma@Advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 27, 2026

Last verified

Dec, 2025

Keywords

  • high blood pressure
  • pre-eclampsia
  • hypertension during pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-27.