Clinical trial NCT01282723: Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
Official title: Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy - Labor Monitoring
Lead sponsor: Reproductive Research Technologies, LP
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.

Brief summary: 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".

Detailed description: 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.

Eligibility 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 age below 37 or above 41 weeks
* Informed consent not given

Primary outcomes:
measure: Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers
timeFrame: 9 - 42 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St.Joseph's Hospital and Medical Center
state: Arizona
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Reproductive Research Technologies, LP
name: Timothy B Waterhouse, MD
role: PRINCIPAL_INVESTIGATOR
References: