Preeclampsia Clinical Trial
— PHANTOMOfficial title:
Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial
Verified date | April 2023 |
Source | Prisma Health-Upstate |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Greenville Memorial Hospital | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Prisma Health-Upstate | Babyscripts, Medical University of South Carolina, South Carolina Telehealth Alliance |
United States,
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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