Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Conditions
Keywords
Fetal Heart Rate (FHR), Uterine Activity (UA), Labor & Delivery
Brief summary
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
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.
Interventions
DEVICEMonica AN24 (K101081)
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
DEVICEPhilips 50XM
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Sponsors
Monica Healthcare Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour | 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. |
| The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM | between 35 mins & 15hrs during first & second stage labor | 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 |
Countries
United States
Participant flow
Recruitment details
Study was from Feb 2010 to Sept 2010 in a clinical setting at Queens Hospital Centre 82 - 68 164th Street Jamaica New York 11432
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded no internal monitoring | 14 |
| Overall Study | IInsufficient data/No data supplied | 12 |
Baseline characteristics
| Characteristic | Monitor With the Philips 50XM, Remove Monica AN24 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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.
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
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM | 84.85 Positive percantage agreement (PPA) |
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.
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
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM | 99.3 Positive percantage agreement (PPA) |
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
Time frame: between 35 mins & 15hrs during first & second stage labor
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM | 96.61 Positive Percentage Agreement (PPA) |