Clinical Trial Update
15 September 2009
Another Australian EPI-NO Clinical Trial near
"EPI-NO System; protection for the pelvic floor?"
An EPI-NO trial at Royal Prince Alfred Hospital, Sydney, and Nepean Hospital, Penrith is studying 200 women expecting their first baby, and the potential protective effect of EPI-NO on the pelvic floor.
Description of the study
The EPI-NO system has already been established as a protective device for the perineum in labour. (German, Australian, Singaporean and Israeli Studies) A prospective randomised controlled study to test a potential protective effect of the EPI-NO system on the pelvic floor structure and function is underway at RPA and Nepean Hospitals. This Trial involves 200 women with a first uncomplicated singleton pregnancy who are being recruited antenatally. The study consists of an interview and translabial ultrasound, with the transducer placed on the perineum (not internally). Patients are being randomised into use of the EPI-NO vs no use. Postpartum an interview and translabial ultrasound is performed to assess the pelvic floor muscles for signs of trauma. The two groups will be compared.
Investigator: Peter Dietz MD PhD FRANZCOG DDU CU Professor in Obstetrics and Gynaecology Nepean Clinical School, University of Sydney
If you are interested in participating in this Trial, and live either in the vicinity of Nepean Hospital Penrith or RPA Hospital Sydney you can contact either:
Dr Clara Shek, Mobile Phone: 0432 910 138, or Research Midwife Susanne Langer, Mobile Phone: 0432 270 614.
