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

This study has been completed.
Sponsor:
Information provided by:
Reproductive Research Technologies, LP
ClinicalTrials.gov Identifier:
NCT01399229
First received: July 19, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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


Condition
Preterm Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm Pregnant Women

Further study details as provided by Reproductive Research Technologies, LP:

Primary Outcome Measures:
  • SureCALL® and TOCO agreement in detecting contraction events [ Time Frame: 10 - 60 minutes ] [ Designated as safety issue: No ]
    The primary outcome measurement was the equivalency between the measurement of contractions by SureCALL® and the predicate TOCO device.


Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant, Preterm
Gestation Age of 36 weeks or less

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

This study involved 25 women at a Gestational Age of 36 weeks or less, at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:

  1. a tocodynamometer attached to the maternal abdomen,
  2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen
  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm women with uncomplicated singleton pregnancies

Criteria

Inclusion Criteria:

  • Singleton Pregnancy
  • Gestation Age of 36 weeks or less
  • Informed Consent Required

Exclusion Criteria:

  • Multifetal pregnancy
  • Gestational Age of more than 36 weeks
  • Informed Consent not given
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399229

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19101
United States, Texas
Southeast Texas OB/GYN Associates
Beaumont, Texas, United States, 77702
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Woman's Hospital of Texas
Houston, Texas, United States, 77054
Sponsors and Collaborators
Reproductive Research Technologies, LP
Investigators
Principal Investigator: Timothy B Waterhouse, MD Reproductive Research Technologies, LP
  More Information

No publications provided

Responsible Party: Jack McCrary, Reproductive Research Technologies, LP
ClinicalTrials.gov Identifier: NCT01399229     History of Changes
Other Study ID Numbers: RRT-11-01
Study First Received: July 19, 2011
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 18, 2013