NCT04474704已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cheetah® non-invasive cardiac monitoring system (Device)
Standard of care
Other
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
干预措施: Standard of care (Other)
结局指标
主要结局
Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
时间窗: up to 24 hours postpartum
次要结局
- Use of Acute Anti-hypertensive Medications(Up to 5 days after delivery)
- Evaluating Number of Participants With Hospital Readmission for Preeclampsia(up to 4 weeks postpartum)
- Composite of Postpartum Adverse Outcomes(up to 4 weeks after delivery)
- Evaluating Incidence of Need to Restart Magnesium Sulfate(up to 1 week postpartum)
- Need for More Than 1 Dose of Anti-hypertensive Medication(Up to 5 days after delivery)
研究者
Maged Costantine
MD, Professor
Ohio State University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure PatientsHeart Failure, CongestiveNCT00531661CardioMEMS550
尚未招募
不适用
Using 14-day Continuous Electrocardiography Patch Monitoring to Detect Paroxysmal Atrial Fibrillation After StrokeIschemic StrokeAtrial FibrillationNCT05218473Chang Gung Memorial Hospital150
已完成
不适用
Pocket Echocardiography System (PES) for Detection of PDA in NeonatesPatent Ductus ArteriosusNCT01790750University of Florida50
招募中
不适用
Hativ® ELectrocardiogram Monitoring on Patients With Suspected ArrhythmiaArrhythmiaNCT06250712Wonju Severance Christian Hospital588
已完成
不适用
Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch)Atrial FibrillationNCT05686330Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)436