Trial Outcomes & Findings for Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method (NCT NCT01280357)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour

Results posted on

2013-03-21

Participant Flow

Study was from Feb 2010 to Sept 2010 in a clinical setting at Queens Hospital Centre 82 - 68 164th Street Jamaica New York 11432

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

Participant milestones

Participant milestones
Measure	All Participants during labor \& delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 \& the Philips 50XM
Overall Study STARTED	60
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants during labor \& delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 \& the Philips 50XM
Overall Study Excluded no internal monitoring	14
Overall Study IInsufficient data/No data supplied	12

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monitor With the Philips 50XM, Remove Monica AN24 n=60 Participants Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM	84.85 Positive percantage agreement (PPA) Interval 73.84 to 88.89

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM	99.3 Positive percantage agreement (PPA) Interval 91.3 to 100.0

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	All Participants n=32 Participants Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM	96.61 Positive Percentage Agreement (PPA) Interval 93.91 to 99.93

Adverse Events

Philips 50XM,

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monica AN24

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian How

Monica Healthcare Ltd

Phone: +44 (0)115912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60