CompletedNot Applicable

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

United States53 participantsStarted 2021-02-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.

Timeframe: up to 24 hours postpartum

Trial details

NCT IDNCT04474704

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-01

Results submitted2023-05-11

View on ClinicalTrials.gov More Preeclampsia With Severe Features trials