Pregnancy - Labor Monitoring
Conditions
Brief 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.
Detailed description
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 measurement 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: 1. a tocodynamometer attached to the maternal abdomen 2. a set of abdominal surface electrodes for uterine electromyography, and 3. an intrauterine pressure catheter. Using IUPC as the gold standard, this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.
Interventions
None listed
Sponsors
Reproductive Research Technologies, LP
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC | 9 - 42 Minutes | Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant, In Labor Monitored simultaneously by SureCALL®, TOCO, and IUPC | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pregnant, In Labor |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age Continuous | 24.85 years STANDARD_DEVIATION 4.38 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC
Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.
Time frame: 9 - 42 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregnant, In Labor | Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC | SureCALL® and IUPC Peak Time Difference | -0.73 Seconds | Standard Deviation 9.22 |
| Pregnant, In Labor | Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC | TOCO and IUPC Peak Time Difference | -1.74 Seconds | Standard Deviation 8.25 |
Comparison: Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.p-value: 0.04627Mixed Models Analysis
Comparison: Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.p-value: 0.1676Mixed Models Analysis