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NCT01399229 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01399229
Other study ID # RRT-11-01
Secondary ID
Status Completed
Phase N/A
First received July 19, 2011
Last updated August 28, 2013
Start date January 2007
Est. completion date December 2011

Study information
Verified date August 2013
Source Reproductive Research Technologies, LP
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

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 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:

1. Standard tocodynamometer attached to the maternal abdomen,

2. 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Singleton Pregnancy

- Informed Consent Required

Exclusion Criteria:

- Multifetal Pregnancy

- Informed Consent Not Given

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Southeast Texas OB/GYN Associates Beaumont Texas
United States University of Texas Medical Branch Galveston Texas
United States Woman's Hospital of Texas Houston Texas
United States Drexel University College of Medicine Philadelphia Pennsylvania
United States St. Joseph's Hospital and Medical Center Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Reproductive Research Technologies, LP

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing Time Stamps of the Peaks of Corresponding Contractions 9 - 41 Minutes No
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