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

Preeclampsia With Severe Features Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474704
• Other study ID #: 2020H0264
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia With Severe Features

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluating Incidence of Need to Restart Magnesium Sulfate		up to 1 week postpartum
Secondary	Evaluating Number of Participants With Hospital Readmission for Preeclampsia		up to 4 weeks postpartum
Secondary	Use of Acute Anti-hypertensive Medications		Up to 5 days after delivery
Secondary	Need for More Than 1 Dose of Anti-hypertensive Medication		Up to 5 days after delivery