NCT01360905

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

Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Monica Healthcare Ltd · Industry
• Sex: Female
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Clinical Investigation for a non-inferiority/equivalence study that aims to determine the acceptable performance of the Monica AN24 during the first and when possible the second stages of labor by determining whether the Monica AN24 fetal heart rate (FHR) and uterine contractions (UC) monitoring device is non-inferior/equivalent to Doppler FHR and tocodynamometer UC using direct fetal scalp electrode (FSE) FHR and intrauterine pressure catheter (IUPC) UC as a reference, either collected simultaneously with the Monica and Doppler FHR/tocodynamometer UC data, or from previous studies to define the expected accuracy and success rate when comparing Monica FHR and UC with Doppler FHR and tocodynamometer UC respectively

Conditions

• Pre Term Labor
• Multiple Pregnancy

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-07-01
• Completion: 2014-01-01
• First posted: 2011-05-26
• Last updated: 2014-01-20

Locations

1 site across 1 country: United States