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

January 21, 2011
February 16, 2011
August 2008
January 2010   (final data collection date for primary outcome measure)
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.
Determine that there was no Significant Difference between SureCALL® and TOCO, as compared to the IUPC, in detecting contractions events as identified by Readers. [ Time Frame: 9 - 42 Minutes ] [ Designated as safety issue: No ]
The Substantial Equivalence of the two devices, SureCALL® compared to TOCO, was determined by the evaluation of Significant Difference between the odds ratio of SureCALL® to IUPC and TOCO to IUPC based on the identification of uterine labor contraction events by readers. Reader Correspondence was determined by a General Linear Mixed Model.
Complete list of historical versions of study NCT01282723 on ClinicalTrials.gov Archive Site
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Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
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".

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

Pregnancy - Labor Monitoring
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Pregnant, In Labor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
15 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01282723
RRT-10-01
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Jack McCrary, Managing Director, Reproductive Research Technologies, LP
Reproductive Research Technologies, LP
Not Provided
Principal Investigator: Timothy B Waterhouse, MD Reproductive Research Technologies, LP
Reproductive Research Technologies, LP
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP