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

NCT04823949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-05-18

Study results available
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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

Interventions

DEVICE

Home blood pressure monitoring

See arm description

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER
  • South Carolina Telehealth Alliance

    collaborator OTHER
  • Babyscripts

    collaborator INDUSTRY
  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Renata Sawyer, MD · Prisma Health-Upstate

  • David Soper, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-01-18
Completion
2022-01-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823949 on ClinicalTrials.gov