Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitor Philips 50XM (K954351) | Active Comparator | CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM |
|
| Monica AN24 (K101801) | Experimental | EHG Fetal Monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monica AN24 (K101081) | Device | If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wayne Cohen, MD | Queens Hospital Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queens Hospital Center | New York | New York | 11432 | United States | ||
| Temple University |
For all participants if there is any issue or exclusion from monitoring with the Monica AN24, fetal monitoring should continue using the Philips 50xm device
Study was from Feb 2010 to Sept 2010 in a clinical setting at Queens Hospital Centre 82 - 68 164th Street Jamaica New York 11432
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | during labor & delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 & the Philips 50XM |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Monitor With the Philips 50XM, Remove Monica AN24 | Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Of the remaining 34 participants in the clinical trials.The data was collected in the following manner. 31 participants were used in FDA 6 way trial for Fetal Heart Rate (FHR) and Uterine Activity (UA) 2 participants were used in a 3 way trial for FHR 1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA | Posted | Mean | 95% Confidence Interval | Positive Percentage Agreement (PPA) | between 35 mins & 15hrs during first & second stage labor |
|
Adverse event data was monitored for the full length of the clinical trial, 6 months in total
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Philips 50XM, | Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian How | Monica Healthcare Ltd | +44 (0)115912 | 4540 | ianhow@monicahealthcare.com |
Not provided
| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Philips 50XM | Device | If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM |
|
| Philadelphia |
| Pennsylvania |
| 19140 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Of the remaining 34 participants in the clinical trials.The data was collected in the following manner. 31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR 1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA | Posted | Mean | 95% Confidence Interval | Positive percantage agreement (PPA) | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour |
|
|
|
| Primary | 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. | Of the remaining 34 participants in the clinical trials.The data was collected in the following manner. 31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR 1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA | Posted | Mean | 95% Confidence Interval | Positive percantage agreement (PPA) | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Monica AN24 | Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM | 0 | 60 | 0 | 60 |
Not provided