N/A
Completed N=20
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
Pregnancy - Labor Monitoring
Source: ClinicalTrials.gov NCT01282723 ↗
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, as Identified by Readers — 1.47; 0.85 Odds Ratio — p=0.0093
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".
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 |
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
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. Informational only — not medical advice.