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Completed

NCT Number: NCT01282723

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

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".

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Key information

Conditions

Pregnancy - Labor Monitoring

Age range

15 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® 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:

  • a tocodynamometer attached to the maternal abdomen
  • a set of abdominal surface electrodes for uterine electromyography, and
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers

    Time frame: 9 - 42 Minutes

    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.

Sponsors and collaborators

Lead sponsor

Reproductive Research Technologies, LP

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2011
Registry last updated
Mar 15, 2011

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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