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

Primary Purpose

Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monica AN24 (K101081)
Philips 50XM
Sponsored by
Monica Healthcare Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy; Habitual Aborter focused on measuring Fetal Heart Rate (FHR), Uterine Activity (UA), Labor & Delivery

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Queens Hospital Center
  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monitor Philips 50XM (K954351)

Monica AN24 (K101801)

Arm Description

CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM

EHG Fetal Monitor

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
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

Full Information

First Posted
January 19, 2011
Last Updated
March 20, 2013
Sponsor
Monica Healthcare Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01280357
Brief Title
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Official Title
Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Monica Healthcare Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Keywords
Fetal Heart Rate (FHR), Uterine Activity (UA), Labor & Delivery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitor Philips 50XM (K954351)
Arm Type
Active Comparator
Arm Description
CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Arm Title
Monica AN24 (K101801)
Arm Type
Experimental
Arm Description
EHG Fetal Monitor
Intervention Type
Device
Intervention Name(s)
Monica AN24 (K101081)
Other Intervention Name(s)
Philips Series 50XM (K954351)
Intervention Description
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Intervention Type
Device
Intervention Name(s)
Philips 50XM
Intervention Description
If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Primary Outcome Measure Information:
Title
The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
Description
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.
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
Title
The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
Description
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.
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
Secondary Outcome Measure Information:
Title
The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
Description
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
Time Frame
between 35 mins & 15hrs during first & second stage labor

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Cohen, MD
Organizational Affiliation
Queens Hospital Centre
Official's Role
Study Director
Facility Information:
Facility Name
Queens Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

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

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