Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women
This measurement 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".
Pregnancy - Labor Monitoring
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement in Pregnant Women|
- Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC [ Time Frame: 9 - 42 Minutes ] [ Designated as safety issue: No ]Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.
|Study Start Date:||August 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Pregnant, In Labor|
The SureCALL® EMG Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
This measurement study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:
- a tocodynamometer attached to the maternal abdomen
- a set of abdominal surface electrodes for uterine electromyography, and
- an intrauterine pressure catheter.
Using IUPC as the "gold standard", this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.
|United States, Arizona|
|St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85004|
|United States, Pennsylvania|
|Drexel University College of Medicine|
|Philadelphia, Pennsylvania, United States, 19102|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Timothy B Waterhouse, MD||Reproductive Research Technologies, LP|