Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
NCT04474704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2023-06-28
Summary
This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:
* 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
* Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.
Conditions
- Preeclampsia With Severe Features
Interventions
- DEVICE
-
Cheetah® non-invasive cardiac monitoring system
Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))
- OTHER
-
Standard of care
24 hours of postpartum magnesium sulfate
Sponsors & Collaborators
-
Ohio State University
lead OTHER
Principal Investigators
-
Maged Costantine, MD · Ohio State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-22
- Primary Completion
- 2022-04-01
- Completion
- 2022-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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