St. Mary's Health Center
St Louis, Missouri, 63117, United States
Completed
NCT Number: NCT02546011
The Monica Fetal Heart Monitor
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.
Completed
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Notify MeKey information
Conditions
Age range
13 year–55 year
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Fetal Heart Rate Monitor
OtherStandard of care, not part of research
Primary outcomes
-
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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
St. Louis University
Other
Registry information
Official study title
The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Sep 10, 2015
- Registry last updated
- Aug 5, 2016
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.