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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reproductive Research Technologies, LP
ClinicalTrials.gov Identifier:
NCT01730963
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).


Condition
Pregnancy

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 and Nonlaboring Patients by Practicing Clinicians

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

Primary Outcome Measures:
  • Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers [ Time Frame: 9 - 41 Minutes ] [ Designated as safety issue: No ]
    Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO.


Enrollment: 30
Study Start Date: January 2007
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant, Preterm, In Labor
Gestation Age at or less than 36 weeks, clinically determined to be in labor
Pregnant, Preterm, Nonlaboring
Gestation Age at or less than 36 weeks, clinically determined to not be in labor
Pregnant, Term, Nonlaboring
Gestation Age more than 36 weeks, clinically determined to not be in labor

Detailed Description:

The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, 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).

This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:

  1. Standard tocodynamometer attached to the maternal abdomen,
  2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen

An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of both labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal as recorded by each labor monitor device.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women with uncomplicated singleton pregnancies

Criteria

Inclusion Criteria:

  • Singleton Pregnancy
  • Informed Consent Required

Exclusion Criteria:

  • Multifetal Pregnancy
  • 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: NCT01730963

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, 19101
United States, Texas
Southeast Texas OB/GYN Associates
Beaumont, Texas, United States, 77702
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Woman's Hospital of Texas
Houston, Texas, United States, 77054
Sponsors and Collaborators
Reproductive Research Technologies, LP
Investigators
Study Director: Timothy B Waterhouse, MD Reproductive Research Technologies, LP
  More Information

No publications provided

Responsible Party: Reproductive Research Technologies, LP
ClinicalTrials.gov Identifier: NCT01730963     History of Changes
Other Study ID Numbers: RRT-12-01
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014