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The Monica Fetal Heart Monitor

S

Saint Louis University (SLU)

Status

Completed

Conditions

Fetal Heart Tracing

Treatments

Other: Fetal Heart Rate Monitor

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Female

Ages

13 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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