NCT02546011

The Monica Fetal Heart Monitor

The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 13 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.

Detailed description

If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours. The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour. Total time of patient's involvement will be 7 hours.

Conditions

• Fetal Heart Tracing

Interventions

Type	Name	Description
OTHER	Fetal Heart Rate Monitor	Standard of care, not part of research

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-09-10
• Last updated: 2016-08-05

Locations

1 site across 1 country: United States