双球囊导管促足月妊娠产妇宫颈成熟的临床研究

Clinical study of double-balloon catheter in full-term pregnancy to promote cevical maturity

目的·探讨双球囊导管在促足月妊娠产妇宫颈成熟及引产中的有效性和安全性。方法·采用前瞻性对照研究的方法,选择2014年5月—2016年1月有引产指征、单胎初产、胎儿头位、胎膜完整、宫颈Bishop评分<6分的152例足月妊娠产妇进行分析;其中51例采用双球囊导管促宫颈成熟者为球囊组,51例采用地诺前列酮栓者为对照组A,50例采用小剂量缩宫素者为对照组B,观察比较3组促宫颈成熟和引产的效果、分娩方式、围产结局、产程等。结果·152例产妇中,球囊组促宫颈成熟有效48例(94.1%),对照组A有效47例(92.2%),对照组B有效16例(32.7%),球囊组总有效率显著高于对照组B(P=0.000),与对照组A差异无统计学意义(P=0.872)。球囊组阴道分娩37例(72.6%),对照组A阴道分娩39例(76.5%),对照组B阴道分娩19例(38.0%),球囊组阴道分娩率明显高于对照组B(P=0.006),与对照组A差异无统计学意义(P=0.747)。而3组的总产程、羊水污染率、新生儿窒息率、产后出血等母儿结局之间差异无统计学意义(P>0.05)。引产过程中产妇不良反应发生率球囊组明显低于对照组A(P=0.003),与对照组B差异无统计学意义(P=0.873)。结论·双球囊导管促宫颈成熟及引发自然分娩效果与地诺前列酮栓无明显差异,但明显优于单纯使用缩宫素,且其不良反应发生率明显低于地诺前列酮栓。

Objective·To evaluate the efficacy and safety of double-balloon catheters in cervical ripening and labor induction among full-term pregnantwomen.Methods·This prospective randomized study was conducted between May2014and January2015.A total of152full-term primiparas inneed of labor induction were recruited.These women were pregnant with single fetuses with vertex presentation and intact membranes,whose Bishopscores were below6.They were randomly assigned to catheter group(51cases),control group A(51cases)and control group B(50cases),who receivedcervical ripening with double-balloon catheters,dinoprostone suppositories,and continuous intravenous infusion of oxytocin,respectively.The efficiencyof cervical ripening and labor induction,labor modes,perinatal outcomes,delivery courses of3groups were recorded and compared.Results·Fortyeightcases(94.1%)in catheter group succeeded in cervical ripening,while47cases(92.2%)in control group A and16cases(32.7%)in control groupB.Double-balloon catheters exhibited to be more effective than intravenous infusion of oxytocin in control group B(P=0.000),but there was nosignificant difference between catheter group and control group A.Thirty-seven women(72.6%)in catheter group,compared with39women(76.5%)in control group A and19women(38.0%)in control group B achieved vaginal delivery.Higher vaginal delivery rate were found in catheter groupthan in control group B(P=0.006).No significant difference was found between catheter group and control group A(P=0.747).Besides,there was nosignificant difference in total labor duration,as well as in the incidences of amniotic fluid contamination,postpartum hemorrhage and neonatal asphyxiaamong the three groups(P>0.05).Less adverse reactions were found in catheter group than those in control group A(P=0.003)instead of in controlgroup B(P=0.873).Conclusion·Double-balloon catheters present similar effects with dinoprostone suppositories in preinduction cervical ripeningand labor induction,obviously more effective than single use of oxytocin.Furthermore,double-balloon catheters cause less side effects than dinoprostonesuppositories.