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

NCT01280357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-03-21

Study results available
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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.

Conditions

  • Pregnancy; Habitual Aborter
  • Weeks of Gestation 37 or More

Interventions

DEVICE

Monica AN24 (K101081)

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

Sponsors & Collaborators

  • Monica Healthcare Ltd

    lead INDUSTRY

Principal Investigators

  • Wayne Cohen, MD · Queens Hospital Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280357 on ClinicalTrials.gov