促子宫颈成熟球囊改善子宫颈条件66例临床观察

Clinical analysis of double-balloon catheter for cervical ripening in 66 cases

目的 探讨促子宫颈成熟球囊在足月妊娠产妇引产过程中改善子宫颈条件的有效性及安全性.方法 本研究应用前瞻性对照研究方法,选取2011年8月至2013年4月北京大学第一医院因妊娠期并发症或合并症而需要引产的足月单胎妊娠产妇128例为观察对象,并随机分为两组：使用促子宫颈成熟球囊66例为球囊组,前列腺素E2阴道用药62例为对照组.比较两组产妇子宫颈条件改善的有效性及不良反应的发生情况.结果 球囊组与对照组产妇子宫颈条件改善的有效性（Bishop评分改善＞2分）无明显差异,改善率分别为82％（54/66）、81％（50/62）,两组比较,差异无统计学意义（P＞0.05）.球囊组产妇从放置至临产的时间长于对照组[分别为（24.2±8.5）、（14.5±8.0） h,P＜0.05];球囊组放置12h内临产率低于对照组,分别为9％（6/66） 、21％（13/62）,两组比较,差异有统计学意义（P＜0.05）;两组产妇的剖宫产率比较无明显差异[分别为41％（27/66）、43％（27/62）,P＞0.05].球囊组产妇临床诊断为宫内感染的发生率较对照组增高[分别为11％（7/66）、6％（4/62）,P＜0.05].球囊组产妇宫缩过频[分别为0（0/66）、42％（26/62）]、体温升高[分别为3％（2/66）、19％（12/62）]、取出前胎心率异常[分别为5％ （3/66）、19％（12/62）]、急产[分别为2％（1/66）、16％（10/62）]的发生率均明显低于对照组（P均＜0.05）.结论 经子宫颈放置促子宫颈成熟球囊与阴道用前列腺素类制剂改善子宫颈条件的效果近似,但前者可能增加宫内感染的风险.经子宫颈放置球囊对母体及胎儿的安全性优于阴道用前列腺素类制剂,可考虑使用促子宫颈成熟球囊改善子宫颈条件以增加引产的成功率.

Objective To evaluate the efficacy and safety for cervical ripening by double-balloon catheter among full-term pregnancy women underwent labor induction.Methods It was a prospective nonrandomly controlled research.Totally 128 singleton-pregnancy women in full-term who had to undergo labor induction because of pregnancy complications or comorbidities from August 2011 to April 2013 in Peking University First Hospital were selected as study subjects.Participants were allocated to preinduction cervical ripening with either a double-balloon catheter （66 participants,study group） or prostaglandin vaginal insert （62 participants,control group）.Compare the efficacy for cervical ripening and adverse reactions between the two groups.Results The efficacy for cervical ripening （Bishop scores improved by ≥ 2） had no significant differences between study and control groups [82% （54/66） compared with 81% （50/ 62）,P〉0.05].The time interval between intervention and parturiency was significantly higher in the doubleballoon catheter group than in the prostaglandin vaginal insert group [（24.2±8.5） compared with （14.5±8.0） hours,P〈0.05].The proportion of women who achieved parturiency within 12 hours was significantly lower in the double-balloon catheter group than that in the control group [9% （6/66） compared with 21% （13/62）,P〈0.05].The cesarean section rate showed no significant differences [41% （27/66） compared with 43%（27/62）,P〉0.05].The prevalence of intrauterine infection demonstrated by clinical diagnosis was significantly higher in the double-balloon catheter group [11% （7/66） compared with 6% （4/62）,P〈O.05].The double-balloon catheter group had significantly lower rates of contraction overfrequency [0（0/66） compared with 42% （26/62）,P〈0.05],hyperthermia [3% （2/66） compared with 19% （12/62）,P〈0.05],fetal heart rate abnormalities before removing the device or drug [5% （3/66） compared with 19% （12/62）,P〈0.05],as well as precipitate labour [2% （1/66） compared with 16% （10/62）,P〈0.05].Conclusions The efficacy of a double-balloon transcervieal catheter is similar to that of a prostaglandin vaginal insert.However,the double-balloon catheter cannot significantly reduce the cesarean section rate while it increases the risk of intrauterine infection.The materual and fetal safety of transcervical catheter is superior to the prostaglandin vaginal insert.In cases of oligohydramnios,fetal growth restriction,pregnancy complicated with asthma,hypertension and scar uterine are in favor of a balloon catheter using for cervical ripening on account of high risk of using prostaglandin.