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

Reproductive Research Technologies

Status

Completed

Conditions

Pregnancy - Labor Monitoring

Study type

Observational

Funder types

Industry

Identifiers

NCT01282710

RRT-09-01

Details and patient eligibility

About

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".

Full description

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.

Enrollment

20 patients

Sex

Female

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria