单、双球囊促宫颈成熟并引产有效性和安全性比较

Transcervical single balloon versus double balloon for cervical ripening and labor induction

目的:探讨单、双球囊两种机械引产方式的有效性和安全性。方法:采用前瞻性随机对照研究方法,收集2013年5月至2017年8月在武汉大学人民医院产科采用单、双球囊催引产的研究对象共1 422例,其中单球囊组146例,双球囊组1 276例。方法:由高年资医师宫颈评分后放置单、双球囊催引产,比较两组催引产方法的有效性和安全性。结果:单、双球囊催引产宫颈成熟率分别为97. 26%、98. 51%,差异无统计学意义(P>0. 05)。比较单、双球囊催引产有效性,发现两组间产妇剖宫产率、阴道分娩率、产程等均无显著差异(P>0. 05),但单球囊组球囊放置至分娩时间明显短于双球囊组(P<0. 05)。而在引产过程新生儿窒息率、新生儿Apgar评分、胎儿窘迫、产妇引产相关并发症发生率均无显著差异(P>0. 05)。结论:单、双球囊催引产安全性无显著性差异,但单球囊催引产球囊放置至分娩的时间显著短于双球囊组。此外,Foley单球囊的单价明显低于COOK双球囊。结论:Foley单球囊催引产是一种相对经济、有效的引产方式。

Objective:To compare the efficacy and safety of the use of transcervical single catheter versus double cervical ripening balloons.Methods:A prospective cohort study was designed and conducted in the Department of Obstetrics of Renmin Hospital of Wuhan University from May 2013 to August2017.A total of 1 422 pregnant women with kinds of indications of labor induction were recruited into this study.They were randomized into two groups:In groupⅠ(n=146),cervical ripening was done using single catheter balloon.In groupⅡ(n=1 276),cervical ripening was done using double cathe-ter balloons.Main outcome measures,including cervical ripening rate,the way of delivery,balloon insertion to delivery interval,Bishop score change,maternal and infant adverse events,were compared.Results:Bishop scores increased significantly in both two groups(P<0.05).However,cervi-cal ripening rate,cesarean section rate,vaginal delivery rate,and labor process were not significantly different between the two groups(P>0.05),while balloon insertion to delivery interval was significantly shorter in groupⅠ(P<0.05).There were no significant differences between the two groups in neonatal asphyxia rate,neonatal Apgar score,fetal distress,and maternal induction-related compli-cations as bleeding,infection,uterine hyperstimulation,unbearable abdominal pain,bladder retention,etc.(P>0.05).Conclusion:There are no significant difference in the safety of single versus dou-ble balloon induction groups,but balloon insertion to delivery interval is significantly shorter in single catheter balloon group.However,the cost of Foley′s single balloon is significantly lower than the COOK double balloon in terms of price.In summary,single catheter balloon induction is a relatively economical and effective method of labor induction.