The Monica Fetal Heart Monitor

NCT ID: NCT02546011

Last Updated: 2016-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Fetal Heart Tracing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fetal Heart Rate Monitor

Standard of care, not part of research

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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[email protected]

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Fruhman, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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St. Mary's Health Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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24511

Identifier Type: -

Identifier Source: org_study_id

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