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Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians

NCT01282723 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2011-03-15

Study results available
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Summary

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".

Conditions

  • Pregnancy - Labor Monitoring

Sponsors & Collaborators

  • Reproductive Research Technologies, LP

    lead INDUSTRY

Principal Investigators

  • Timothy B Waterhouse, MD · Reproductive Research Technologies, LP

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282723 on ClinicalTrials.gov