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

NCT04474704 | Completed Results FDA Device

• 1 other identifier: 2020H0264
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia With Severe Features

Keywords

preeclampsia with severe features; magnesium sulfate; Systemic Vascular Resistance; non-invasive cardiac monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Composite of Postpartum Adverse Outcomes

  up to 4 weeks after delivery

• Evaluating Incidence of Need to Restart Magnesium Sulfate

  up to 1 week postpartum

• Evaluating Number of Participants With Hospital Readmission for Preeclampsia

  up to 4 weeks postpartum

• Use of Acute Anti-hypertensive Medications

  Up to 5 days after delivery

• Need for More Than 1 Dose of Anti-hypertensive Medication

  Up to 5 days after delivery

Study Arms (2)

Cheetah® non-invasive cardiac monitoring system

EXPERIMENTAL

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.

Device: Cheetah® non-invasive cardiac monitoring system

Standard of care

OTHER

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

Other: Standard of care

Interventions

Cheetah® non-invasive cardiac monitoring system DEVICE

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))

Cheetah® non-invasive cardiac monitoring system

Standard of care OTHER

24 hours of postpartum magnesium sulfate

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Maged Costantine, MD
• Organization: The Ohio State University

Maged.Costantine@osumc.edu

614-293-2222

Study Officials

• Maged Costantine, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 17, 2020
• Study Start: February 22, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 31, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)