Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women

Completed

Conditions studied: Pregnancy - Labor Monitoring

In brief

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".

Key facts

Study ID

NCT01282710

Run by

Reproductive Research Technologies, LP

People needed

20

Starts

2008-08-01

Expected to finish

2008-12-01

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 ages 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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