评估COOK宫颈扩张球囊促宫颈成熟并引产的有效性、安全性及使用技巧。

选择2011年1月至2013年12月在成都市妇女儿童中心医院产科应用COOK宫颈扩张球囊促宫颈成熟(部分孕妇合并使用缩宫素)并引产及同期直接使用缩宫素静脉滴注引产的共计390例孕妇为研究对象。按照是否使用COOK宫颈扩张球囊促宫颈成熟，将其分为实验组(n＝195，使用)及对照组(n＝195，未使用)。分析比较两组受试者妊娠合并症、宫颈Bishop评分、围生儿结局、引产过程、引产结局及不良事件发生率。两组受试者一般临床资料比较，差异无统计学意义(P>0.05)。本研究遵循的程序符合成都市妇女儿童中心医院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象知情同意，并与之签署临床研究知情同意书。

取出球囊后，实验组宫颈Bishop评分较放置前显著升高，且差异有统计学意义(q＝4.564，P＝0.000)；并显著高于对照组，且差异有统计学意义(q＝5.282，P＝0.000)。实验组引产成功率显著高于对照组，而实验组引产失败率和要求剖宫产率均显著低于对照组，且差异均有统计学意义(χ²＝10.029，9.176，7.131；P<0.05)。从静脉滴注缩宫素到分娩结束的时间、给予缩宫素引产次数及产后出血量均显著少于对照组，且差异有统计学意义(t＝18.376，63.533，52.733；P<0.005)；两组第一产程时间、宫颈裂伤发生率及阴道血肿发生率比较，其差异均无统计学意义(t/χ²＝0.152，0.352，0.000；P>0.05)。实验组和对照组围生儿结局比较，其差异均无统计学意义(P>0.05)。实验组出现胎膜自发性破裂、球囊自行掉出、发热、自发性产程启动及胎盘早剥等不良事件。

COOK宫颈扩张球囊能有效促进宫颈成熟，使用后进行引产未出现严重不良结局。放置COOK宫颈扩张球囊前应常规做白带常规检查，放置的最佳时间为夜间入睡前，球囊取出后给予人工破膜引产，对破膜困难者，不应强行进行人工破膜。

To evaluate the effectiveness, safety and place skills of COOK balloon for cervical ripening and labor induction.

A total of 390 pregnant women inducted by COOK balloon combined with oxytocin and inducted only by oxytocin in the Department of Obstetrics, Chengdu Women and Children's Central Hospital, from January 2011 to December 2013 were recorded and analyzed. According to whether to use COOK cervical dilatation balloon for cervical ripening or not, they were divided into experimental group(n=195, use) and control group(n=195, not use). The pregnancy complications, cervical Bishop score, perinatal outcomes, induction process, induction outcomes and the incidence of adverse events were analyzed and compared. The general clinical data of two groups were compared with no statistically significant difference (P>0.05). The study protocol was approved by the Ethical Review Board of Investigation in Human Beings of Chengdu Women and Children's Central Hospital.Informed consent was obtained from each participating patient.

After balloon removed, the cervical Bishop score of experimental group increased significantly (q=4.564, P=0.000); and was significantly higher than that of control group(q=5.282, P=0.000). The successful induction rate in experimental group was significantly higher than that in control group but the induced failure rate and cesarean section rate by request in experimental group were significantly lower than those in control group (χ²=10.029, 9.176, 7.131; P<0.05). The duration from oxytocin was given to the end of delivery, the duration of oxytocin used and the amount of postpartum hemorrhage of experimental group were significantly less than those in control group (t=18.376, 63.533, 52.733; P<0.05). There were no significant differences between two groups about duration of first stage of labor, the incidence of cervical laceration and vaginal hematoma(t/χ²=0.152, 0.352, 0.000; P>0.05). There were no significant differences between two groups about perinatal outcomes(P>0.05). The fetal membrane broken autonomously, balloon fell out, fever, spontaneous labor start, and placental abruption occurred in experimental group.

COOK cervical dilatation balloon can effectively promote cervical mature with no obvious adverse outcomes.The leucorrhea must be conducted routine examination before placing the balloon, the best time of balloon placed was in the night before going to sleep. After balloon removed, membranes should be artificial ruptured before induction of labor. The fetal membrane should not be ruptured by force if it is difficult to rupture.