Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
Completed
Conditions studied: Pregnancy - Labor Monitoring
In brief
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".
Key facts
- Study ID
- NCT01282723
- Run by
- Reproductive Research Technologies, LP
- People needed
- 20
- Starts
- 2008-08-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2011-03-15
Who can join
Age: 15 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Singleton Pregnancy
- Indicated for IUPC
- Gestational ages from 37 to 41 weeks
- Informed consent required
You may not qualify if…
- Multifetal pregnancy
- Not Indicated for IUPC
- Gestation age below 37 or above 41 weeks
- Informed consent not given
Where it is running
- St.Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
- Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
- University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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