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一项关于Kiwi Omnicup与传统吸引杯用于真空辅助阴道分娩的前瞻性随机对照试验。

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

作者信息

Groom K M, Jones B A, Miller N, Paterson-Brown S

机构信息

Department of Obstetrics and Gynaecology, Queen Charlotte's and Chelsea Hospital, London, UK.

出版信息

BJOG. 2006 Feb;113(2):183-9. doi: 10.1111/j.1471-0528.2005.00834.x.

DOI:10.1111/j.1471-0528.2005.00834.x
PMID:16411996
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.

摘要

目的

评估奇异果全能吸杯的性能及安全性,并在常规临床实践中将其与传统吸杯进行比较。

设计

奇异果全能吸杯与传统吸杯的随机对照试验。

地点

2001年4月至2004年3月期间,位于伦敦的一家三级转诊医院——夏洛特女王与切尔西医院。

研究对象

需要借助胎头吸引器进行助产的女性。

方法

将女性随机分为奇异果全能吸杯组(n = 206)和传统吸杯组(n = 198)。收集产妇人口统计学资料、分娩情况、分娩方式以及母婴结局等数据。

主要观察指标

首选器械助产失败情况。

结果

在首选器械助产方面,奇异果全能吸杯的成功率低于传统胎头吸引器,失败率分别为30.1%和19.2%(相对危险度1.58;95%置信区间1.10 - 2.24)。它与更多次数的吸杯脱落相关(平均0.68次与0.28次相比,至少有一次脱落的比例分别为44%和18%[P < 0.0001])。严重母体创伤的发生率没有差异,也没有严重新生儿损伤的病例。

结论

在实现阴道分娩方面,奇异果全能吸杯不如传统胎头吸引器成功,但其安全性相当。

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