Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.
The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
60
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Queens Hospital Center
New York, New York, United States
Temple University
Philadelphia, Pennsylvania, United States
The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
During Labor \& delivery, fetal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
During Labor \& delivery, maternal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
During labor and delivery uterine contractions were measured between the Monica AN24 \& the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement
Time frame: between 35 mins & 15hrs during first & second stage labor
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