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

Not Applicable

Completed

• Conditions: Preeclampsia With Severe Features
• Interventions: Other: Standard of care; Device: Cheetah® non-invasive cardiac monitoring system

• Registration Number: NCT04474704
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-17
• Study Start: 2021-02-22
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-31
• Results First Submitted: 2023-05-11
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Results First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Cheetah® non-invasive cardiac monitoring system	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Need for More Than 1 Dose of Anti-hypertensive Medication	Up to 5 days after delivery
Composite of Postpartum Adverse Outcomes	up to 4 weeks after delivery	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
Evaluating Incidence of Need to Restart Magnesium Sulfate	up to 1 week postpartum

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine; 🇺🇸 Columbus, Ohio, United States