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Clinical Trials/NCT04823949
NCT04823949
Completed
Not Applicable

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

Prisma Health-Upstate2 sites in 1 country202 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Hypertension
Sponsor
Prisma Health-Upstate
Enrollment
202
Locations
2
Primary Endpoint
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
January 18, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum

Time Frame: 10 days

How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists

Secondary Outcomes

  • Initiation of Antihypertensive After Discharge(16 days)
  • Unscheduled Visits(16 days)
  • Readmission(6 weeks)
  • Attended Postpartum Visit(6 weeks)

Study Sites (2)

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