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

March 20, 2013 updated by: Monica Healthcare Ltd

Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11432
        • Queens Hospital Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Philips Series 50XM (K954351)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between 35 mins & 15hrs during first & second stage labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monica Healthcare Ltd

Investigators

  • Study Director: Wayne Cohen, MD, Queens Hospital Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (ESTIMATE)

January 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHL101801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy; Habitual Aborter

Clinical Trials on Philips 50XM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe