Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia

Use of Cheetah® Non-invasive Cardiac Monitoring System to Guide Discontinuation of Postpartum Magnesium Sulfate in Women With Severe Preeclampsia: A Pilot Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia With Severe Features
• Intervention / Treatment: Device: Cheetah® non-invasive cardiac monitoring system; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Preeclampsia with severe features, diagnosed using the American Congress of Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate
• Females older than 18 years of age
• Singleton pregnancy
• Gestational age greater than 24 0/7 weeks
• The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
• Able to speak English or Spanish

Exclusion Criteria:

• Multiple gestation
• Prisoners
• Patients with chronic renal insufficiency or epilepsy
• Known cardiovascular disease
• Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)
• Patients with eclampsia or HELLP syndrome
• Contraindications for magnesium sulfate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cheetah® non-invasive cardiac monitoring system; Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.	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 (current arbitrary standard of care)	Other: Standard of care; 24 hours of postpartum magnesium sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.	up to 24 hours postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Postpartum Adverse Outcomes	any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as >160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia	up to 4 weeks after delivery
Evaluating Incidence of Need to Restart Magnesium Sulfate		up to 1 week postpartum
Evaluating Number of Participants With Hospital Readmission for Preeclampsia		up to 4 weeks postpartum
Use of Acute Anti-hypertensive Medications		Up to 5 days after delivery
Need for More Than 1 Dose of Anti-hypertensive Medication		Up to 5 days after delivery

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Maged Costantine, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: magnesium sulfate; preeclampsia with severe features; Systemic Vascular Resistance; non-invasive cardiac monitoring
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia
• Other Study ID Numbers: 2020H0264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No