Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 20, 2011
CompletedResults Posted
Study results publicly available
March 21, 2013
CompletedMarch 21, 2013
March 1, 2013
4 months
January 19, 2011
August 11, 2011
March 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
between 35 mins & 15hrs during first & second stage labor
Study Arms (2)
Monitor Philips 50XM (K954351)
ACTIVE COMPARATORCTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Monica AN24 (K101801)
EXPERIMENTALEHG Fetal Monitor
Interventions
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
Eligibility Criteria
You may qualify if:
- Pregnant, age 15-40
- Term gestation (\>36 completed weeks)
- Singleton fetus
- Active labor
- Vertex presentation
- Requiring internal monitoring
You may not qualify if:
- Clinical contraindication for Intra Uterine Pressure Catheter
- Major fetal malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Queens Hospital Center
New York, New York, 11432, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ian How
- Organization
- Monica Healthcare Ltd
Study Officials
- STUDY DIRECTOR
Wayne Cohen, MD
Queens Hospital Centre
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 20, 2011
Study Start
February 1, 2010
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
March 21, 2013
Results First Posted
March 21, 2013
Record last verified: 2013-03