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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730963
• Other study ID #: RRT-12-01
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: November 20, 2012
• Start date: January 2007
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Reproductive Research Technologies, LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton Pregnancy

• Informed Consent Required

Exclusion Criteria:

• Multifetal Pregnancy

• Informed Consent Not Given

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	Southeast Texas OB/GYN Associates	Beaumont	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	Woman's Hospital of Texas	Houston	Texas
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Research Technologies, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers	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.	9 - 41 Minutes	No