Expired Study
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Phoenix, Arizona 85004


Purpose:

This measurement 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".


Study summary:

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 measurement 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. Using IUPC as the "gold standard", this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.


Criteria:

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 ages below 37 or above 41 weeks - Informed consent not given


Study is Available At:


Original ID:

RRT-09-01


NCT ID:

NCT01282710


Secondary ID:


Study Acronym:


Brief Title:

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women


Official Title:

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement in Pregnant Women


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

15 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Reproductive Research Technologies, LP


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Timothy B Waterhouse, MD
Principal Investigator
Reproductive Research Technologies, LP

Study Dates

Start Date:August 2008
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:February 2011
Last Changed Date:February 16, 2011
First Received Date:January 21, 2011
First Results Date:January 24, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC
Time Frame:9 - 42 Minutes
Safety Issues:False
Description:Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Pregnant, In Labor

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Reproductive Research Technologies, LP

Samples and Retentions

Study Population: Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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