Trials Sponsors Conditions Drugs Pricing

Conditions

Preeclampsia With Severe Features

Keywords

preeclampsia with severe featuresmagnesium sulfateSystemic Vascular Resistancenon-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 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))

Cheetah® non-invasive cardiac monitoring system

Standard of careOther

24 hours of postpartum magnesium sulfate

Standard of care

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Ohio State University
Otherlead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

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

Study Officials

Maged Costantine, MD
Ohio State University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

53 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Cheetah® non-invasive cardiac monitoring system

Standard of care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Cheetah® non-invasive cardiac monitoring system

Standard of care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations