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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth, HELLP Syndrome

Intervention / Treatment
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* Device: Home blood pressure monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum | |
| Experimental: Intervention<br>Patient 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 | Device: Home blood pressure monitoring<br>* See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of Antihypertensive After Discharge | How many participants required initiation of antihypertensive after discharge | 16 days | 
| Unscheduled Visits | Number of participants with unscheduled visits | 16 days | 
| Readmission | Number of participants readmitted postpartum | 6 weeks | 
| Attended Postpartum Visit | Number of participants who attended their postpartum visit | 6 weeks |