Status:
COMPLETED
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
Lead Sponsor:
Reproductive Research Technologies, LP
Conditions:
Pregnancy
Eligibility:
FEMALE
18-40 years
Brief Summary
This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.
Detailed Description
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using ...
Eligibility Criteria
Inclusion
- Singleton Pregnancy
- Informed Consent Required
Exclusion
- Multifetal Pregnancy
- Informed Consent Not Given
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01399229
Start Date
January 1 2007
End Date
December 1 2011
Last Update
September 12 2013
Active Locations (5)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19101
3
Southeast Texas OB/GYN Associates
Beaumont, Texas, United States, 77702
4
University of Texas Medical Branch
Galveston, Texas, United States, 77555