Back to resultsUse of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
Primary Purpose
Preeclampsia With Severe Features
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cheetah® non-invasive cardiac monitoring system
Standard of care
Sponsored by
About this trial
This is an interventional other trial for Preeclampsia With Severe Features focused on measuring preeclampsia with severe features, magnesium sulfate, Systemic Vascular Resistance, non-invasive cardiac monitoring
Eligibility Criteria
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
Sites / Locations
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cheetah® non-invasive cardiac monitoring system
Standard of care
Arm 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.
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Outcomes
Primary Outcome Measures
Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
Secondary Outcome Measures
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
Evaluating Incidence of Need to Restart Magnesium Sulfate
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
Use of Acute Anti-hypertensive Medications
Need for More Than 1 Dose of Anti-hypertensive Medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04474704
Brief Title
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia With Severe Features
Keywords
preeclampsia with severe features, magnesium sulfate, Systemic Vascular Resistance, non-invasive cardiac monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cheetah® non-invasive cardiac monitoring system
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
Other
Arm Description
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Intervention Type
Device
Intervention Name(s)
Cheetah® non-invasive cardiac monitoring system
Intervention Description
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))
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
24 hours of postpartum magnesium sulfate
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Composite of Postpartum Adverse Outcomes
Description
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
Title
Evaluating Incidence of Need to Restart Magnesium Sulfate
Time Frame
up to 1 week postpartum
Title
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
Time Frame
up to 4 weeks postpartum
Title
Use of Acute Anti-hypertensive Medications
Time Frame
Up to 5 days after delivery
Title
Need for More Than 1 Dose of Anti-hypertensive Medication
Time Frame
Up to 5 days after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged Costantine, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
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