Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians

This study has been completed.
Sponsor:
Information provided by:
Reproductive Research Technologies, LP
ClinicalTrials.gov Identifier:
NCT01282723
First received: January 21, 2011
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

This multi-reader multi-case 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".


Condition
Pregnancy - Labor Monitoring

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians

Further study details as provided by Reproductive Research Technologies, LP:

Primary Outcome Measures:
  • Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers [ Time Frame: 9 - 42 Minutes ] [ Designated as safety issue: No ]
    The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.


Enrollment: 20
Study Start Date: August 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant, In Labor

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 multi-reader multi-case 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.

An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of the three independent labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal produced by a full-term patient in term labor as independently collected by each labor monitor device.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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 age below 37 or above 41 weeks
  • Informed consent not given
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282723

Locations
United States, Arizona
St.Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
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
Sponsors and Collaborators
Reproductive Research Technologies, LP
Investigators
Principal Investigator: Timothy B Waterhouse, MD Reproductive Research Technologies, LP
  More Information

No publications provided

Responsible Party: Jack McCrary, Managing Director, Reproductive Research Technologies, LP
ClinicalTrials.gov Identifier: NCT01282723     History of Changes
Other Study ID Numbers: RRT-10-01
Study First Received: January 21, 2011
Results First Received: January 24, 2011
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014