CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Monica AN24 (K101081) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01280357N/ACompleted
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Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

Monica Healthcare Ltd·interventional·Posted Jan 20, 2011·Updated Mar 21, 2013

In Brief

A clinical study evaluating Monica AN24 (K101081) and Philips 50XM for Pregnancy; Habitual Aborter and Weeks of Gestation 37 or More. Completed, enrolled 60 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy; Habitual Aborter, Weeks of Gestation 37 or More
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2011
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.5 years ago

Interventions

Monica AN24 (K101081)device

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

Philips 50XMdevice

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