MedPath

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

Not Applicable
Completed
Conditions
Preeclampsia
Chronic Hypertension With Pre-Eclampsia Complicating Childbirth
HELLP Syndrome
Gestational Hypertension
Interventions
Device: Home blood pressure monitoring
Registration Number
NCT04823949
Lead Sponsor
Prisma Health-Upstate
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
202
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionHome blood pressure monitoringPatient 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
Primary Outcome Measures
NameTimeMethod
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum10 days

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
NameTimeMethod
Initiation of Antihypertensive After Discharge16 days

How many participants required initiation of antihypertensive after discharge

Unscheduled Visits16 days

Number of participants with unscheduled visits

Readmission6 weeks

Number of participants readmitted postpartum

Attended Postpartum Visit6 weeks

Number of participants who attended their postpartum visit

Trial Locations

Locations (2)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Greenville Memorial Hospital

🇺🇸

Greenville, South Carolina, United States

© Copyright 2025. All Rights Reserved by MedPath