Telehealth and remote blood pressure management for pregnant women with chronic high blood pressure
Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy
This study tests whether alternating telehealth visits with home blood pressure monitoring and health coaching helps pregnant women (18–45) with chronic high blood pressure compared with standard in-person care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT07356518 on ClinicalTrials.gov |
What this trial studies
Pregnant women with chronic hypertension are assigned to either alternating telehealth visits with remote blood pressure monitoring plus five health coaching sessions or to standard in-person clinic visits. Telehealth participants alternate telehealth and clinic visits every two weeks until pregnancy week 31 and receive five phone or video coaching sessions through week 36, while the control group follows usual in-person care. The study focuses on feasibility outcomes (willingness to enroll, completion rate, adherence to monitoring) and also explores safety outcomes related to blood pressure control and pregnancy complications through delivery. Participation continues until the baby is delivered and requires the ability to use telehealth technology and plan to deliver at the study hospital.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18–45 with a documented diagnosis of chronic hypertension or on antihypertensive medication before pregnancy who receive prenatal care and plan to deliver at Atrium Health Wake Forest Baptist.
Not a fit: Patients with severe hypertension, significant cardiac disorders, multifetal pregnancy, current substance abuse, prior stroke, major fetal abnormalities, or those planning to deliver outside the study hospital are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce in-person visit burden, improve home blood pressure monitoring and medication adherence, and potentially lower hypertension-related admissions during pregnancy.
How similar studies have performed: Some prior digital blood pressure management programs in high-risk pregnancies showed fewer hypertension-related admissions, but evidence specifically for chronic hypertension in pregnancy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Aderonke O Adeniyi, MD, MS — Wake Forest University Health Sciences
- Study coordinator: Ejiro Obioma, MBBS MMCi
- Email: Ejiro.Obioma@Advocatehealth.org
- Phone: 704-355-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.