NCT01280357

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Monica Healthcare Ltd · Industry
• Sex: Female
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-06-01
• Completion: 2010-09-01
• First posted: 2011-01-20
• Last updated: 2013-03-21
• Results posted: 2013-03-21

Locations

2 sites across 1 country: United States