An observational study in Pregnancy - Labor Monitoring, sponsored by Reproductive Research Technologies, LP. Completed at 3 sites in United States. Open to female participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2011-03-15.
Sponsored by Reproductive Research Technologies, LP · Observational
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".
The SureCALL® EMG Labor Monitor® (SureCALL®)is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of the three independent labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal produced by a full-term patient in term labor as independently collected by each labor monitor device.
Reproductive Research Technologies, LP is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.
Exclusion Criteria:
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers
The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.
Time frame: 9 - 42 Minutes
| Milestone | Pregnant, In Labor |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.
| Odds Ratio | Pregnant, In Labor |
|---|---|
| True Positive Fraction | 1.47 (1.10 to 1.95) |
| False Positive Fraction | 0.85 (0.61 to 1.17) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregnant, In Labor | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Pregnant, In Labor |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 18 |
| >=65 years | 0 |
| Age Continuous(years) | Pregnant, In Labor |
|---|---|
| Mean | 24.85 ± 4.38 |
| Sex: Female, Male(Participants) | Pregnant, In Labor |
|---|---|
| Female | 20 |
| Male | 0 |
| Region of Enrollment(participants) | Pregnant, In Labor |
|---|---|
| United States | 20 |
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Reproductive Research Technologies, LP