Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies

Stopped early

Conditions studied: Pre Term Labor, Multiple Pregnancy

In brief

The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.

Key facts

Study ID

NCT01360905

Run by

Monica Healthcare Ltd

People needed

8

Starts

2011-05-01

Expected to finish

2014-01-01

Last updated by the study team

2014-01-20

Who can join

Age: 17 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• She is >=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or >=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit
• She is in the latent phase of spontaneous labor, or has been admitted for induction of labor
• She has given her informed consent to participate as a subject
• She has none of the exclusion criteria

You may not qualify if…

• Known major fetal malformation or chromosome abnormality
• Involvement in another clinical trial currently or previously in this pregnancy
• Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives)
• Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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