Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians

Study Overview
=================
Brief Summary
-----------------
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).

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 multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO). 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 and not in labor 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 An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of both labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal as recorded by each labor monitor device.

Official Title
-----------------
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton Pregnancy Informed Consent Required Exclusion Criteria: Multifetal Pregnancy Informed Consent Not Given

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant, Preterm, In Labor<br>Gestation Age at or less than 36 weeks, clinically determined to be in labor | |
| Pregnant, Preterm, Nonlaboring<br>Gestation Age at or less than 36 weeks, clinically determined to not be in labor | |
| Pregnant, Term, Nonlaboring<br>Gestation Age more than 36 weeks, clinically determined to not be in labor | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers | Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO. | 9 - 41 Minutes |