Preeclampsia With Severe FeaturesNCT04474704

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

A study testing Cheetah® non-invasive cardiac monitoring system in people with Preeclampsia With Severe Features, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Preeclampsia With Severe Features
What is being tested?: Cheetah® non-invasive cardiac monitoring system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 22 Feb 2021to 31 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210

Other trials in United States

About this study

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

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
Being tested: Cheetah® non-invasive cardiac monitoring system, Standard of care
Keywords: preeclampsia with severe features, magnesium sulfate, Systemic Vascular Resistance, non-invasive cardiac monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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))
Standard of careOther
24 hours of postpartum magnesium sulfate

Study groups in NCT04474704
Study group	Role	What they receive
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. Receives: Device: Cheetah® non-invasive cardiac monitoring system
Standard of care	Other	24 hours of postpartum magnesium sulfate (current arbitrary standard of care) Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
Measured: up to 24 hours postpartum

Secondary outcomes (5)

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
Measured: up to 4 weeks after delivery
Evaluating Incidence of Need to Restart Magnesium Sulfate
Measured: up to 1 week postpartum
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
Measured: up to 4 weeks postpartum
Use of Acute Anti-hypertensive Medications
Measured: Up to 5 days after delivery
Need for More Than 1 Dose of Anti-hypertensive Medication
Measured: Up to 5 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202131 May 2022

First posted17 Jul 2020
Study start22 Feb 2021
Primary completion1 Apr 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Preeclampsia With Severe FeaturesStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04474704
Sponsor's protocol ID: 2020H0264
Status last verified: Jun 2023
First submitted: 8 Jul 2020
Last updated: 28 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
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Recruiting
Role of Postpartum Furosemide in Recovery of Patients With Severe Preeclampsia
Severe Preeclampsia

All Preeclampsia With Severe Features trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04474704
Acronym / sponsor ID: 2020H0264
Conditions: Preeclampsia With Severe Features
Keywords: preeclampsia with severe features, magnesium sulfate, Systemic Vascular Resistance, non-invasive cardiac monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: 22 Feb 2021 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 17 Jul 2020 (actual)
Results: Posted 28 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cheetah® non-invasive cardiac monitoring system	Experimental	Device: Cheetah® non-invasive cardiac monitoring systemUsing 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.
Standard of care	Other	Other: Standard of care24 hours of postpartum magnesium sulfate (current arbitrary standard of care)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

Multiple gestation
Prisoners
Patients with chronic renal insufficiency or epilepsy
Known cardiovascular disease
Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cheetah® non-invasive cardiac monitoring systemCheetah® 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))	Device	Cheetah® non-invasive cardiac monitoring system
Standard of care24 hours of postpartum magnesium sulfate	Other	Standard of care

Primary outcome

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

5 secondary outcomes

Composite of Postpartum Adverse Outcomes
Time frame: up to 4 weeks after delivery
Evaluating Incidence of Need to Restart Magnesium Sulfate
Time frame: up to 1 week postpartum
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
Time frame: up to 4 weeks postpartum
Use of Acute Anti-hypertensive Medications
Time frame: Up to 5 days after delivery
Need for More Than 1 Dose of Anti-hypertensive Medication
Time frame: Up to 5 days after delivery

Results and safety

Results posted to the registry on 28 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cheetah® Non-invasive Cardiac Monitoring System	21	21
Standard of Care	26	26

Primary outcome: 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. Mean (Standard Deviation). Unit: hours

Measure	Cheetah® Non-invasive Cardiac Monitoring System n = 21	Standard of Care n = 26
Value	21.6 (4.7)	24 (0)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: After up to 4 weeks postpartum. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cheetah® Non-invasive Cardiac Monitoring System	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Standard of Care	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Preeclampsia With Severe Features

Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Recruiting
Role of Postpartum Furosemide in Recovery of Patients With Severe Preeclampsia
Severe Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maged Costantine, MD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cheetah® non-invasive cardiac monitoring system in people with Preeclampsia With Severe Features, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04474704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.