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

Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia; HELLP Syndrome; Gestational Hypertension; Chronic Hypertension With Pre-Eclampsia Complicating Childbirth
• Intervention / Treatment: Device: Home blood pressure monitoring

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum
Experimental: Intervention; 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	Device: Home blood pressure monitoring; See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum	How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of Antihypertensive After Discharge	How many participants required initiation of antihypertensive after discharge	16 days
Unscheduled Visits	Number of participants with unscheduled visits	16 days
Readmission	Number of participants readmitted postpartum	6 weeks
Attended Postpartum Visit	Number of participants who attended their postpartum visit	6 weeks

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Medical University of South Carolina; South Carolina Telehealth Alliance; Babyscripts
• Investigators: Principal Investigator: Renata Sawyer, MD, Prisma Health-Upstate; Principal Investigator: David Soper, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; HELLP Syndrome
• Other Study ID Numbers: Pro00090951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No