Pregnancy
Conditions
Brief 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.
Detailed description
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, 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® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients. This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity: 1. Standard tocodynamometer attached to the maternal abdomen, 2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen Subjects did not recieve any interventions as a part of this study.
Interventions
None listed
Sponsors
Reproductive Research Technologies, LP
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Singleton Pregnancy * Informed Consent Required
Exclusion criteria
* Multifetal Pregnancy * Informed Consent Not Given
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing | 9 - 41 Minutes | Time Stamps of the Peaks of Corresponding Contractions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Pregnant |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 29.50 years STANDARD_DEVIATION 6.75 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 30 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 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing
Time Stamps of the Peaks of Corresponding Contractions
Time frame: 9 - 41 Minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Patents With Uterine Contractions | Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing | 0.99 Seconds | Standard Deviation 15.17 |
p-value: 0.490195% CI: [-28.74, 30.72]Mixed Models Analysis