Skip to content

The Monica Fetal Heart Monitor

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02546011
Enrollment
36
Registered
2015-09-10
Start date
2014-01-31
Completion date
2016-07-31
Last updated
2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Heart Tracing

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.

Interventions

Standard of care, not part of research

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 deviceHow long can hetal heart tracings be capture continuouslyThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026