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

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter 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".

Study Overview

• Status: Completed
• Conditions: Pregnancy - Labor Monitoring

Detailed 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:

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 (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • St. Joseph's Hospital and Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant, In Labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 - 42 Minutes

Collaborators and Investigators

• Sponsor: Reproductive Research Technologies, LP

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): March 15, 2011
• Last Update Submitted That Met QC Criteria: February 16, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: RRT-09-01