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

Ohio State University53 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Preeclampsia With Severe Features

Interventions

Cheetah® non-invasive cardiac monitoring systemDEVICE

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))

Standard of careOTHER

24 hours of postpartum magnesium sulfate

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

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

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

Time frame: up to 4 weeks after delivery

Evaluating Incidence of Need to Restart Magnesium Sulfate

Time frame: up to 1 week postpartum

Evaluating Number of Participants With Hospital Readmission for Preeclampsia

Time frame: up to 4 weeks postpartum

Use of Acute Anti-hypertensive Medications

Time frame: Up to 5 days after delivery

Need for More Than 1 Dose of Anti-hypertensive Medication

Time frame: Up to 5 days after delivery

Data from ClinicalTrials.gov

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