Clinical Trials

Australian Clinical Trial

Summary: Conducted at Box Hill Hospital, Melbourne,  under Prof.Gab.Kovacs, 48 first-time mothers who used EPI-NO were compared with all other primigravida at Box Hill who delivered in the same period. The Study shows a highly significantly improved outcome for the perineum when compared to the Control Group. Discussion: EPI-NO should be offered as an option to all  first time mothers  to use during the late third trimester.  This Trial can be accessed in full, and downloaded from this website.

First German Clinical Trial

Summary: Conducted at the Technical University of Munich, under Prof. K.T.M.Schneider, 50 first-time mothers who used EPI-NO were compared in matched pairs for rates of episiotomy, perineal tears, fetal APGAR Scores, duration of labour and analgesia during delivery.  Anxiety  was  measured in both groups outside the scope of the Trial. A significant reduction was found in the rate of episiotomy, perineal tears for EPI-NO users was half that of the Control, and a significant shortening in 2nd Stage Labour was determined. The EPI-NO group required less analgesics, and their babies had better APGAR Scores. A reduction in Anxiety levels was identified.

Israeli Midwife Study 

Summary: An interview questionaire of 233 women who had used EPI-NO was conducted in Israel by Judy Slome-Cohain ANM, MSN, an American-Israeli RN/Midwife. The results of their childbirth experience was compared with published perinatal statistics for mothers birthing in Israel. The Study showed that  women  who had trained with EPI-NO had a lower episiotomy rate. The majority of women reported an increased confidence in their ability to birth, and that EPI-No prepared them for the sensations of pushing and the birth. 98% of the women interviewed stated that they would recommend using EPI-NO.

German Multi-Centre Clinical Trial

Summary: A multi-centre randomised single-blind EPI-NO Study was undertaken in four university hospitals in Germany. The Study of 276 first-time mothers under Dr Eugen Ruckhaberle included hospitals in Frankfurt, Munich and Ulm. The aim of the Study was to verify the preliminary positive results of EPI-NO use in previous studies, but in a new high compliance prospective randomised trial. The study concluded that training with EPI-NO increases significantly the liklihood of having an intact perineum and reduces the episiotomy rate. This study was published in the Australian and New Zealand Journal of Obstetrics and Gynaecology Volume 49, No.5, October 2009.

 

Australian & NZ Journal of Gynaecology 2004 Journal of Obstetrics & Neonatology 2001 (Germany) MIDIRS Midwifery Digest 2004 Australian & NZ Journal of Gynaecology 2009

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