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NCT Number: NCT07356518

Telehealth and Remote Blood Pressure

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Ejiro Obioma, MBBS MMCi

CONTACT

[email protected]

704-355-2000

About this study

Hypertension (HTN) in pregnancy requires weekly or bi-weekly in-person visits. Telehealth visits with remote blood pressure (BP) telemonitoring may be an alternative to frequent in-person visits improve adherence. However, the feasibility of this approach in pregnancy is lacking and studies are limited on the use of remote BP telemonitoring in chronic HTN (cHTN) during pregnancy. A digital health platform for BP management in pregnant women at risk for preeclampsia (women with cHTN, prior preeclampsia or kidney disease) found fewer admissions for HTN or suspected preeclampsia in the intervention compared to usual care. There is a critical need to investigate the feasibility (willingness and adherence), and safety of this intervention. Without ascertaining the feasibility of telehealth and remote BP monitoring, it remains a challenge to tackle the no-show rates and suboptimal medication adherence during pregnancy.

Objectives Aim 1: To determine the feasibility of incorporating telehealth clinic visits with remote BP telemonitoring alternating with in-person clinic visits in the management of cHTN in pregnancy in the clinic by evaluating willingness to enroll, completion rate and adherence versus standard care (in-person clinic visits alone). This working hypothesis is that this approach will be as feasible as standard care.

Aim 2: To explore safety outcomes of telehealth clinic visits combined with blood pressure remote telemonitoring alternating with in-person clinic visits in the management of chronic hypertension in pregnant patients in the clinic by measuring the incidence of hypotension, syncope or hospitalization/emergency room visits for severe HTN compared to standard care. The working hypothesis is that this approach will be comparable in safety to standard care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telehealth visits

Behavioral

remote visits with participants

In-person visits

Behavioral

standard of care visits with care provider in person

Primary outcomes

  1. Feasibility of telehealth with remote BP telemonitoring compared to standard care

    Time frame: Gestational Week 31

    willingness to enroll (number of patients enrolled divided by number of patients reached), study completion rate, adherence compared to standard care). Adherence will be defined as taking medication at least ≥80% of the time, recording ≥70% of weekly BP readings in the intervention group only and completing ≥70% of antenatal telehealth/clinic visits.

  2. Safety of telehealth combined with telemonitoring compared to standard care

    Time frame: Gestational Week 31

    The number of adverse events reported (hypotension, syncope or hospitalization/emergency room visit for severe HTN

Secondary outcomes

  1. Patient satisfaction Scores

    Time frame: Gestational Week 31

    at the end of 31 weeks, each participant will complete a patient research satisfaction survey - Strongly disagree 0, disagree 1, neither agree nor disagree 2, agree 3, strongly agree 4

  2. Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores

    Time frame: Gestational Week 31

    at the end of 31 weeks, each provider of record for each participant will be invited to complete a research satisfaction survey. Nurses, medical assistants, schedulers at the Comprehensive Fetal Care Center who have participated in the telehealth visit with remote monitoring will be invited to complete a research satisfaction survey - Strongly disagree 0, disagree 1, neither agree nor disagree 2, agree 3, strongly agree 4

Study contacts

Contact information is provided by the study sponsor or research team.

Aderonke Adeniyi, MD, MS

CONTACT

[email protected]

337 713 2278

Ejiro Obioma, MBBS MMCi

CONTACT

[email protected]

704-355-2000

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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