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Completed

NCT Number: NCT01730963

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

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

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Key information

Conditions

Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

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About this study

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:

  • Standard tocodynamometer attached to the maternal abdomen,
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton Pregnancy
  • Informed Consent Required

Exclusion criteria

  • Multifetal Pregnancy
  • Informed Consent Not Given

Treatment and study plan

Primary outcomes

  1. Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers

    Time frame: 9 - 41 Minutes

    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.

Sponsors and collaborators

Lead sponsor

Reproductive Research Technologies, LP

Industry

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Nov 21, 2012
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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