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

NCT ID: NCT01280357

Last Updated: 2013-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy; Habitual Aborter Weeks of Gestation 37 or More

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Philips 50XM

Intervention Type DEVICE

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

Monica AN24 (K101801)

EHG Fetal Monitor

Group Type EXPERIMENTAL

Monica AN24 (K101081)

Intervention Type DEVICE

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

Interventions

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Monica AN24 (K101081)

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

Intervention Type DEVICE

Philips 50XM

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

Intervention Type DEVICE

Other Intervention Names

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Philips Series 50XM (K954351)

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Monica Healthcare Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wayne Cohen, MD

Role: STUDY_DIRECTOR

Queens Hospital Centre

Locations

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Queens Hospital Center

New York, New York, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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MHL101801

Identifier Type: -

Identifier Source: org_study_id

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