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

Reproductive Research Technologies

Status: Completed

Conditions: Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01730963

RRT-12-01

Details and patient eligibility

About

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

Full 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:

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

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Singleton Pregnancy
• Informed Consent Required

Exclusion criteria

• Multifetal Pregnancy
• Informed Consent Not Given

Trial design

30 participants in 3 patient groups

Pregnant, Preterm, In Labor

Description:

Gestation Age at or less than 36 weeks, clinically determined to be in labor

Pregnant, Preterm, Nonlaboring

Description:

Gestation Age at or less than 36 weeks, clinically determined to not be in labor

Pregnant, Term, Nonlaboring

Description:

Gestation Age more than 36 weeks, clinically determined to not be in labor