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

The Ohio State University

Status: Completed

Conditions: Preeclampsia With Severe Features

Treatments: Other: Standard of care; Device: Cheetah® non-invasive cardiac monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT04474704

2020H0264

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Cheetah® non-invasive cardiac monitoring system

Experimental group

Description:

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.

Treatment:

Device: Cheetah® non-invasive cardiac monitoring system

Standard of care

Other group

Description:

24 hours of postpartum magnesium sulfate (current arbitrary standard of care)

Treatment:

Other: Standard of care