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

Reproductive Research Technologies, LP20 enrolled

Overview

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".

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: 1. a tocodynamometer attached to the maternal abdomen 2. a set of abdominal surface electrodes for uterine electromyography, and 3. 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy - Labor Monitoring

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Singleton Pregnancy * Indicated for IUPC * Gestational ages from 37 to 41 weeks * Informed consent required Exclusion Criteria: * Multifetal Pregnancy * Not Indicated for IUPC * Gestation ages below 37 or above 41 weeks * Informed consent not given

Locations (3)

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

Outcomes

Primary Outcomes

Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC

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.

Time frame: 9 - 42 Minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.