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Completed

NCT Number: NCT01399229

Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women

This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.

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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 measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.

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 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

Subjects did not recieve any interventions as a part of this study.

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 Event Timing

    Time frame: 9 - 41 Minutes

    Time Stamps of the Peaks of Corresponding Contractions

Sponsors and collaborators

Lead sponsor

Reproductive Research Technologies, LP

Industry

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 21, 2011
Registry last updated
Sep 12, 2013

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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