Pregnancy - Labor Monitoring
Conditions
Brief 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.
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 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: 1. a tocodynamometer attached to the maternal abdomen 2. a set of abdominal surface electrodes for uterine electromyography, and 3. an intrauterine pressure catheter. 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.
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 age 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, as Identified by Readers | 9 - 42 Minutes | 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. |
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, 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregnant, In Labor | Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers | True Positive Fraction | 1.47 Odds Ratio |
| Pregnant, In Labor | Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers | False Positive Fraction | 0.85 Odds Ratio |
Comparison: Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®.p-value: 0.009395% CI: [1.1, 1.95]Mixed Models Analysis
Comparison: Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®.p-value: 0.320495% CI: [0.61, 1.17]Mixed Models Analysis