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OpenTrials
Completed

NCT Number: NCT04474704

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

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.

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Key information

Conditions

Preeclampsia With Severe Features

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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))

Standard of care

Other

24 hours of postpartum magnesium sulfate

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.

    Time frame: up to 24 hours postpartum

Secondary outcomes

  1. Composite of Postpartum Adverse Outcomes

    Time frame: up to 4 weeks after delivery

    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

  2. Evaluating Incidence of Need to Restart Magnesium Sulfate

    Time frame: up to 1 week postpartum

  3. Evaluating Number of Participants With Hospital Readmission for Preeclampsia

    Time frame: up to 4 weeks postpartum

  4. Use of Acute Anti-hypertensive Medications

    Time frame: Up to 5 days after delivery

  5. Need for More Than 1 Dose of Anti-hypertensive Medication

    Time frame: Up to 5 days after delivery

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2020
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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