N/A
Completed N=20
Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women
Pregnancy - Labor Monitoring
Source: ClinicalTrials.gov NCT01282710 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC — -0.73; -1.74 Seconds — p=.04627
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".
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 |
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
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. Informational only — not medical advice.