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

Reproductive Research Technologies

Status: Completed

Conditions: Pregnancy - Labor Monitoring

Study type: Observational

Funder types: Industry

Identifiers

NCT01282723

RRT-10-01

Details and patient eligibility

About

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".

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Pregnant, In Labor