Clinical trial NCT04823949: Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Hypertension
Preeclampsia
Chronic Hypertension With Pre-Eclampsia Complicating Childbirth
HELLP Syndrome
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: South Carolina Telehealth Alliance
name: Babyscripts
First posted: 2021-04-01
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
timeFrame: 10 days
Secondary outcomes:
measure: Initiation of Antihypertensive After Discharge
timeFrame: 16 days
measure: Unscheduled Visits
timeFrame: 16 days
measure: Readmission
timeFrame: 6 weeks
measure: Attended Postpartum Visit
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Renata Sawyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: David Soper, MD
role: PRINCIPAL_INVESTIGATOR
References: