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

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04474704

Collaborator

(none)

Enrollment

Location

Arms

18.2

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia With Severe Features	Device: Cheetah® non-invasive cardiac monitoring system Other: Standard of care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 22, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Evaluating 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

Evaluating number of hospital readmission [up to 4 weeks postpartum]
Evaluating change in arterial blood pressure (systolic and diastolic) [up to 24 hours postpartum]
Evaluating change in cardiac output [up to 24 hours postpartum]
Evaluating change in heart rate [up to 24 hours postpartum]
Evaluating incidence of need to restart magnesium sulfate [up to 1 week postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Maged Costantine, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maged Costantine, MD, Professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT04474704

Other Study ID Numbers:

2020H0264

First Posted:

Jul 17, 2020

Last Update Posted:

Oct 12, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Maged Costantine, MD, Professor, Ohio State University

preeclampsia with severe features

magnesium sulfate

Systemic Vascular Resistance

non-invasive cardiac monitoring

Additional relevant MeSH terms:

Pre-Eclampsia

Study Results

No Results Posted as of Oct 12, 2021