Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring (PHANTOM)

Prisma Health-Upstate

Status: Completed

Conditions: Chronic Hypertension With Pre-Eclampsia Complicating Childbirth; Preeclampsia; Gestational Hypertension; HELLP Syndrome

Treatments: Device: Home blood pressure monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04823949

Pro00090951

Details and patient eligibility

About

A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.

Full description

While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.

Enrollment: 202 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution.
• Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.

Exclusion criteria

• <18 years of age
• BMI >50 (due to limitations in blood pressure cuff size through BabyScripts)
• non English-speaking
• not able to receive phone calls and unlimited texts on cell phone
• not able to download and use Babyscripts phone application

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Standard care

No Intervention group

Description:

Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum

Intervention

Experimental group

Description:

Patient will receive a Babyscripts blood pressure cuff(brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge

Treatment:

Device: Home blood pressure monitoring