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

Preeclampsia Clinical Trial

— PHANTOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823949
• Other study ID #: Pro00090951
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: April 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Gestational Hypertension
• HELLP Syndrome
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• Home blood pressure monitoring
See arm description

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Babyscripts, Medical University of South Carolina, South Carolina Telehealth Alliance

Country where clinical trial is conducted

United States, 

Outcome

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