N/A N=20

Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women

Pregnancy - Labor Monitoring

Bottom Line

View on ClinicalTrials.gov: NCT01282710 ↗

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 — -0.73; -1.74 Seconds — p=.04627

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Reproductive Research Technologies, LP
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC	-0.73; -1.74	.04627 sig

Summary

This measurement 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 ages below 37 or above 41 weeks
Informed consent not given

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01282710). 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.