N/A
N=47
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
Preeclampsia With Severe Features
Bottom Line
View on ClinicalTrials.gov: NCT04474704 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate. — 21.6; 24 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cheetah® non-invasive cardiac monitoring system (Device); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate. |
21.6; 24 | — |
| SECONDARY Composite of Postpartum Adverse Outcomes |
6; 7 | — |
| SECONDARY Evaluating Incidence of Need to Restart Magnesium Sulfate |
0; 0 | — |
| SECONDARY Evaluating Number of Participants With Hospital Readmission for Preeclampsia |
0; 1 | — |
| SECONDARY Use of Acute Anti-hypertensive Medications |
6; 7 | — |
| SECONDARY Need for More Than 1 Dose of Anti-hypertensive Medication |
4; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04474704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.