A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery

Abstract

Objective: To evaluate the performance and safety of the Kiwi Omnicup and compare it to conventional vacuum cups in routine clinical practice.

Design: A randomised controlled trial of the Kiwi Omnicup versus conventional vacuum cups.

Setting: Queen Charlotte's and Chelsea Hospital, a tertiary referral hospital in London from April 2001 to March 2004.

Population: Women requiring assisted vaginal delivery by ventouse.

Methods: Women were randomised to the Kiwi Omnicup (n=206) or conventional vacuum cups (n=198). Data regarding maternal demographics, labour, mode of delivery and maternal and neonatal outcome were collected.

Main outcome measures: Failure of delivery with instrument of first choice.

Results: The Kiwi Omnicup was less successful at delivery with instrument of first choice than the conventional ventouse, failure rate 30.1 versus 19.2% (RR 1.58; 95% CI 1.10-2.24). It was associated with a greater number of cup detachments (mean 0.68 compared with 0.28, with 44% compared with 18% having at least one detachment [P<0.0001]). There was no difference in the incidence of severe maternal trauma, and there were no cases of serious neonatal injury.

Conclusions: The Kiwi Omnicup is less successful than conventional ventouse in achieving vaginal delivery, but its safety profile is comparable.