Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring (PHANTOM)
Primary Purpose
Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home blood pressure monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Gestational Hypertension
Eligibility Criteria
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 >40 (due to limitations in BP 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
Sites / Locations
- Medical University of South Carolina
- Greenville Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Intervention
Arm Description
Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Initiation of Antihypertensive After Discharge
How many participants required initiation of antihypertensive after discharge
Unscheduled Visits
Number of participants with unscheduled visits
Readmission
Number of participants readmitted postpartum
Attended Postpartum Visit
Number of participants who attended their postpartum visit
Full Information
NCT ID
NCT04823949
First Posted
December 3, 2020
Last Updated
April 24, 2023
Sponsor
Prisma Health-Upstate
Collaborators
Medical University of South Carolina, South Carolina Telehealth Alliance, Babyscripts
1. Study Identification
Unique Protocol Identification Number
NCT04823949
Brief Title
Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
Acronym
PHANTOM
Official Title
Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
January 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
Medical University of South Carolina, South Carolina Telehealth Alliance, Babyscripts
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth, HELLP Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartum
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum
Arm Title
Intervention
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Home blood pressure monitoring
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
Description
How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Initiation of Antihypertensive After Discharge
Description
How many participants required initiation of antihypertensive after discharge
Time Frame
16 days
Title
Unscheduled Visits
Description
Number of participants with unscheduled visits
Time Frame
16 days
Title
Readmission
Description
Number of participants readmitted postpartum
Time Frame
6 weeks
Title
Attended Postpartum Visit
Description
Number of participants who attended their postpartum visit
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Sawyer, MD
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Soper, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
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