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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280357
First Posted: January 20, 2011
Last Update Posted: March 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Monica Healthcare Ltd
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 ]
    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 ]
    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 ]
    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
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 Name: Philips Series 50XM (K954351)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Monica Healthcare Ltd
ClinicalTrials.gov Identifier: NCT01280357     History of Changes
Other Study ID Numbers: MHL101801
First Submitted: January 19, 2011
First Posted: January 20, 2011
Results First Submitted: August 11, 2011
Results First Posted: March 21, 2013
Last Update Posted: March 21, 2013
Last Verified: March 2013

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