Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

Conditions
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Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More

Intervention / Treatment
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* Device: Monica AN24 (K101081)
* Device: Philips 50XM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant, age 15-40 Term gestation (>36 completed weeks) Singleton fetus Active labor Vertex presentation Requiring internal monitoring Exclusion Criteria: Clinical contraindication for Intra Uterine Pressure Catheter Major fetal malformation

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monitor Philips 50XM (K954351)<br>CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM | Device: Philips 50XM<br>* If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM<br>|
| Experimental: Monica AN24 (K101801)<br>EHG Fetal Monitor | Device: Monica AN24 (K101081)<br>* If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM<br>* Other names: Philips Series 50XM (K954351);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | between 35 mins & 15hrs during first & second stage labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal Heart Rate (FHR), Uterine Activity (UA), Labor & Delivery