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

NCT04823949 | Completed Results FDA Device

• 1 other identifier: Pro00090951
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Initiation of Antihypertensive After Discharge

  16 days

• Unscheduled Visits

  16 days

• Readmission

  6 weeks

• Attended Postpartum Visit

  6 weeks

Study Arms (2)

Standard care

NO INTERVENTION

Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum

Intervention

EXPERIMENTAL

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

Interventions

Home blood pressure monitoring DEVICE

See arm description

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Medical University of South Carolina: collaborator
• South Carolina Telehealth Alliance: collaborator
• Babyscripts: collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Related Publications (1)

• Arkerson BJ, Finneran MM, Harris SR, Schnorr J, McElwee ER, Demosthenes L, Sawyer R. Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial. Obstet Gynecol. 2023 Oct 1;142(4):855-861. doi: 10.1097/AOG.0000000000005327. Epub 2023 Sep 7.

  PMID: 37734091 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; HELLP Syndrome

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Results Point of Contact

• Title: Dr. Matthew Finneran
• Organization: The Medical University of South Carolina

finneram@musc.edu

(843) 792-4500

Study Officials

• Renata Sawyer, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

• David Soper, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: April 1, 2021
• Study Start: April 15, 2021
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)