K M Groom1, B A Jones, N Miller, S Paterson-Brown. 1. Department of Obstetrics and Gynaecology, Queen Charlotte's and Chelsea Hospital, London, UK. katiegroom@xtra.co.nz
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.
RCT Entities:
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.
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