We hypothesize that frequent remote monitoring of blood pressure and real-time antihypertensive medication titration will optimize pregnancy outcomes in a clinically meaningful and cost-effective manner compared to the current standard of care. Therefore, this pilot study, as part of the K12 training support, will evaluate the feasibility of a randomized clinical trial to treat mild chronic hypertension with medication therapy to a blood pressure goal of less than 140/90 mmHg based on remote daily patient monitoring compared to in-office blood pressure readings.
Age 18 or older
Patients with a viable pregnancy <23 weeks of gestation
Chronic hypertension is defined as: 1) Currently receiving treatment for hypertensive disorders OR 2) Newly diagnosed or untreated chronic hypertension is defined as systolic blood pressure >=140 mm Hg or diastolic blood pressure >=90 mm Hg prior to 20 weeks of gestation
Viable pregnancy <23 weeks of gestation
Known secondary cause of hypertension
Known major fetal anomaly
Known fetal demise
Suspected fetal growth restriction
Parallel
Remote Patient Monitoring
Procedure/SurgeryThe patients randomized to this intervention will get set up with remote patient monitoring. For these patients, blood pressure management and medication adjustment will be based on remote blood pressure measurements.
Composite perinatal outcomes
This study will examine a primary composite of perinatal outcomes (Perinatal death, placental abruption, superimposed preeclampsia with severe features, or indicated preterm birth \<35 weeks)
Cardiac strain
Cardiac strain assessments will also be collected at baseline and at 34 to 36 weeks of gestation.
POCUS
Accuracy of POCUS assessment for cardiac strain compared to echocardiograms obtained by a certified echocardiogram technologist.
Accuracy of BP reading
Compliance and similarity between in-office and home blood pressure readings will be evaluated.
Feasibility of study procedures
Feasibility outcomes will focus on developing recruitment procedures, determining consent rate, developing and testing approaches to measure outcomes, testing blood pressure regimen, and determining the feasibility of echocardiogram assessments
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Rutgers, The State University of New Jersey
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
