N/A N=20

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

Pregnancy - Labor Monitoring

Bottom Line

View on ClinicalTrials.gov: NCT01282723 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcome: Primary: Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers — 1.47; 0.85 Odds Ratio — p=0.0093

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Reproductive Research Technologies, LP
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers	1.47; 0.85	0.0093 sig

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".

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01282723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.