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

Ohio State University1 site in 1 country53 target enrollmentFebruary 22, 2021

ConditionsPreeclampsia With Severe Features

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preeclampsia With Severe Features
Sponsor: Ohio State University
Enrollment: 53
Locations: 1
Primary Endpoint: Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 22, 2021

End Date

May 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ohio State University

Responsible Party

Principal Investigator

Maged Costantine

MD, Professor

Ohio State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.

Time Frame: up to 24 hours postpartum

Secondary Outcomes

Use of Acute Anti-hypertensive Medications(Up to 5 days after delivery)
Evaluating Number of Participants With Hospital Readmission for Preeclampsia(up to 4 weeks postpartum)
Composite of Postpartum Adverse Outcomes(up to 4 weeks after delivery)
Evaluating Incidence of Need to Restart Magnesium Sulfate(up to 1 week postpartum)
Need for More Than 1 Dose of Anti-hypertensive Medication(Up to 5 days after delivery)