Objective: To evaluate the performance and verify the safety of the Koala Intrauterine Pressure Catheter (IUPC) in clinical use.
Study design: Twenty IUP Koala Catheters were placed in laboring women. IUPC monitoring provided diagnostic information in assessing the pressures generated by the myometrium during the labor and delivery process. Information was recorded pertaining to the catheters' safety, ease of use, accuracy, zeroing, drift and amnioinfusion capability. Comparisons were made to a preexisting IUPC.
Results: The Koala catheter was safe to introduce into the intrauterine cavity. There were no problems with amnioport communications, connectors, placental perforation, unusual patient discomfort or infections with either the Koala or Intran fluid-filled system. The numerical ratings were compared using the Mann-Whitney test and showed no significant difference between the two groups in safety, zeroing and drift. A statistically significant difference at the .01 level for ease of use, accuracy and setup in favor of the Koala was found.
Conclusion: Clinical study of the Koala Intrauterine Pressure Catheter vs. Intran and the other fluid-filled catheters demonstrated the Koala to be as safe and as functionally effective as, or more effective than, standard IUPCs.