The Monica Fetal Heart Monitor

Completed

• Conditions: Fetal Heart Tracing

• Registration Number: NCT02546011
• Lead Sponsor: St. Louis University

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Pregnant patients between 24 and 28 weeks admitted to the antepartum service

Exclusion Criteria

• Patients with a non viable pregnancy
• Patients with multiple gestation
• Clinically Unstable patients
• Non English speaking patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	How long can hetal heart tracings be capture continuously	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.

Trial Locations

Locations (1)

St. Mary's Health Center; 🇺🇸 St. Louis, Missouri, United States