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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monica Healthcare Ltd
ClinicalTrials.gov Identifier:
NCT01280357
First received: January 19, 2011
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pregnancy; Habitual Aborter
Weeks of Gestation 37 or More
Device: Monica AN24 (K101081)
Device: Philips 50XM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

Further study details as provided by Monica Healthcare Ltd:

Primary Outcome Measures:
  • The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM [ Time Frame: between 35 mins & 15hrs during first & second stage labor ] [ Designated as safety issue: No ]
    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


Enrollment: 60
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monitor Philips 50XM (K954351)
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
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Other Name: Philips 50XM
Experimental: Monica AN24 (K101801)
EHG Fetal Monitor
Device: Monica AN24 (K101081)
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Other Names:
  • Philips Series 50XM (K954351)
  • Monica AN24 (K101081)

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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280357

Locations
United States, New York
Queens Hospital Center
New York, New York, United States, 11432
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Monica Healthcare Ltd
Investigators
Study Director: Wayne Cohen, MD Queens Hospital Centre
  More Information

No publications provided

Responsible Party: Monica Healthcare Ltd
ClinicalTrials.gov Identifier: NCT01280357     History of Changes
Other Study ID Numbers: MHL101801
Study First Received: January 19, 2011
Results First Received: August 11, 2011
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Monica Healthcare Ltd:
Fetal Heart Rate (FHR)
Uterine Activity (UA)
Labor & Delivery

Additional relevant MeSH terms:
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications

ClinicalTrials.gov processed this record on October 30, 2014