N/A
N=30
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01399229 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing — 0.99 Seconds — p=0.4901
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Reproductive Research Technologies, LP
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing |
0.99 | 0.4901 |
Summary
This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.
Eligibility Criteria
Inclusion Criteria
- Singleton Pregnancy
- Informed Consent Required
Exclusion Criteria
- Multifetal Pregnancy
- Informed Consent Not Given
Data sourced from ClinicalTrials.gov (NCT01399229). 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.