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两种用于宫颈成熟的机械装置的比较:一项前瞻性半随机试验。

Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial.

作者信息

Mei-Dan Elad, Walfisch Asnat, Suarez-Easton Sivan, Hallak Mordechai

机构信息

Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera, Israel.

出版信息

J Matern Fetal Neonatal Med. 2012 Jun;25(6):723-7. doi: 10.3109/14767058.2011.591459. Epub 2011 Aug 2.

Abstract

OBJECTIVE

To compare the efficacy of two mechanical devices for cervical ripening: Foley catheter with extra-amniotic saline infusion and the Cook cervical ripening balloon.

METHODS

Women at term with a singleton pregnancy who presented for labor induction were randomly assigned to the Foley catheter or the Cook cervical ripening balloon (costs $3 and $41, respectively). The main outcome measures included time from device insertion to delivery, rates of successful vaginal delivery and occurrence of adverse events.

RESULTS

The study was completed by 188 women. Time from balloon insertion to expulsion and from insertion to delivery was significantly shorter in the Foley catheter group when compared with the Cook cervical ripening balloon group (6.9 ± 4.2 vs. 10.1 ± 4.7 hours, p = .001 and 19.6 ± 11.4 vs. 23.4 ± 15.5 hours, p = .03, respectively). There were no significant differences in other outcomes.

CONCLUSIONS

Considering its shorter induction process and lower cost, Foley catheter with extra-amniotic saline infusion is superior to the Cook cervical ripening balloon for initiating cervical ripening.

摘要

目的

比较两种用于宫颈成熟的机械装置的疗效:带羊膜外生理盐水输注的福莱导尿管和库克宫颈成熟球囊。

方法

足月单胎妊娠且前来引产的女性被随机分配至福莱导尿管组或库克宫颈成熟球囊组(成本分别为3美元和41美元)。主要结局指标包括从装置插入到分娩的时间、阴道分娩成功率及不良事件发生率。

结果

188名女性完成了该研究。与库克宫颈成熟球囊组相比,福莱导尿管组从球囊插入到排出以及从插入到分娩的时间显著更短(分别为6.9±4.2小时对10.1±4.7小时,p = 0.001;19.6±11.4小时对23.4±15.5小时,p = 0.03)。其他结局无显著差异。

结论

考虑到其引产过程更短且成本更低,带羊膜外生理盐水输注的福莱导尿管在启动宫颈成熟方面优于库克宫颈成熟球囊。

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