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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04823949
Other study ID # Pro00090951
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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