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

Completed · Not applicable

Conditions studied: Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More

In brief

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.

Key facts

Study ID

NCT01280357

Run by

Monica Healthcare Ltd

People needed

60

Starts

2010-02-01

Expected to finish

2010-09-01

Last updated by the study team

2013-03-21

Who can join

Age: 15 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant, age 15-40
• Term gestation (>36 completed weeks)
• Singleton fetus
• Active labor
• Vertex presentation
• Requiring internal monitoring

You may not qualify if…

• Clinical contraindication for Intra Uterine Pressure Catheter
• Major fetal malformation

Where it is running

• Queens Hospital Center — New York, New York, United States
• Temple University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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