双球囊导管促足月妊娠产妇宫颈成熟的临床研究
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摘要
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 pregnant women. Methods · This prospective randomized study was conducted between May 2014 and January 2015. A total of 152 full-term primiparas in need of labor induction were recruited. These women were pregnant with single fetuses with vertex presentation and intact membranes, whose Bishop scores were below 6. They were randomly assigned to catheter group(51 cases), control group A(51 cases) and control group B(50 cases), who received cervical ripening with double-balloon catheters, dinoprostone suppositories, and continuous intravenous infusion of oxytocin, respectively. The efficiency of cervical ripening and labor induction, labor modes, perinatal outcomes, delivery courses of 3 groups were recorded and compared. Results · Fortyeight cases(94.1%) in catheter group succeeded in cervical ripening, while 47 cases(92.2%) in control group A and 16 cases(32.7%) in control group B. Double-balloon catheters exhibited to be more effective than intravenous infusion of oxytocin in control group B(P=0.000), but there was no significant difference between catheter group and control group A. Thirty-seven women(72.6%) in catheter group, compared with 39 women(76.5%) in control group A and 19 women(38.0%) in control group B achieved vaginal delivery. Higher vaginal delivery rate were found in catheter group than 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 no significant difference in total labor duration, as well as in the incidences of amniotic fluid contamination, postpartum hemorrhage and neonatal asphyxia among 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 control group B(P=0.873). Conclusion · Double-balloon catheters present similar effects with dinoprostone suppositories in preinduction cervical ripening and labor induction, obviously more effective than single use of oxytocin. Furthermore, double-balloon catheters cause less side effects than dinoprostone suppositories.
Objective · To evaluate the efficacy and safety of double-balloon catheters in cervical ripening and labor induction among full-term pregnant women. Methods · This prospective randomized study was conducted between May 2014 and January 2015. A total of 152 full-term primiparas in need of labor induction were recruited. These women were pregnant with single fetuses with vertex presentation and intact membranes, whose Bishop scores were below 6. They were randomly assigned to catheter group(51 cases), control group A(51 cases) and control group B(50 cases), who received cervical ripening with double-balloon catheters, dinoprostone suppositories, and continuous intravenous infusion of oxytocin, respectively. The efficiency of cervical ripening and labor induction, labor modes, perinatal outcomes, delivery courses of 3 groups were recorded and compared. Results · Fortyeight cases(94.1%) in catheter group succeeded in cervical ripening, while 47 cases(92.2%) in control group A and 16 cases(32.7%) in control group B. Double-balloon catheters exhibited to be more effective than intravenous infusion of oxytocin in control group B(P=0.000), but there was no significant difference between catheter group and control group A. Thirty-seven women(72.6%) in catheter group, compared with 39 women(76.5%) in control group A and 19 women(38.0%) in control group B achieved vaginal delivery. Higher vaginal delivery rate were found in catheter group than 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 no significant difference in total labor duration, as well as in the incidences of amniotic fluid contamination, postpartum hemorrhage and neonatal asphyxia among 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 control group B(P=0.873). Conclusion · Double-balloon catheters present similar effects with dinoprostone suppositories in preinduction cervical ripening and labor induction, obviously more effective than single use of oxytocin. Furthermore, double-balloon catheters cause less side effects than dinoprostone suppositories.
引文
[1]许剑,郭馥艳,陈茵,等.Cook球囊联合缩宫素用于足月孕妇促宫颈成熟及引产效果观察[J].浙江临床医学,2014,16(3):380-381.
[2]谢幸,苟文丽.妇产科学[M].8版.北京:人民卫生出版社,2013:187-189.
[3]范翠芳,孙艳梅,陈建华.双球囊在中晚期高危妊娠引产中应用的有效性及安全性[J].华中科技大学学报(医学版),2012,41(5):636-638.
[4]朱伟英,关怀,李小薇,等.双球囊导管促宫颈成熟及引产效果观察[J].人民军医,2014,57(10):1107-1110.
[5]郑剑兰,付景丽,张小琼,等.双球囊导管及0.8 mm控释地诺前列酮栓在促宫颈成熟与引产方面的随机对照研究[J].中华妇产科杂志,2011,46(8):610-612.
[6]中华医学会妇产科学分会产科学组.妊娠晚期促宫颈成熟与引产指南(2014)[J].中华妇产科杂志,2014,49(12):881-885.
[7]Miller NR,Cypher RL,Foglia LM,et al.Elective induction of labor compared with expectant management of nulliparous women at 39 weeks of gestation:a randomized controlled trial[J].Obstet Gynecol,2015,126(6):1258-1264.
[8]Anabusi S,Mei-Dan E,Hallak M,et al.Mechanical labor induction in the obese population:a secondary analysis of a prospective randomized trial[J].Arch Gynecol Obstet,2016,293(1):75-80.
[9]Prager M,Eneroth-Grimfors E,Edlund M,et al.A randomised controlled trial of intravaginal dinoprostone,intravaginal misoprostol and transcervical balloon catheter for labour induction[J].BJOG,2008,115(11):1443-1450.
[10]魏丽惠.妇产科诊疗常规[M].北京:中国医药科技出版社,2012:279.
[11]Ramirez MM.Labor induction:a review of current methods[J].Obstet Gynecol Clin North Am,2011,38(2):215-225.
[12]Romanelli M,Ribiani E,Burnelli L,et al.Pharmacological induction of labour:benefits and risks[J].Minerva Ginecol,2007,59(4):347-355.
[13]白桂芹,付逢萍,王慰敏.宫颈促成熟球囊在临床计划分娩中的作用[J].中国妇幼健康研究,2011,22(2):179-181.
[14]张建平,包琳.正确掌握引产催产方法[J].中国实用妇科与产科杂志,2012,28(2):89-93.
[15]Mukhopadhyay M,Lim KJ,Fairlie FM.Is propess a better method of induction of labour in nulliparous women[J].J Obstet Gynaecol,2002,22(3):294-295.
[16]Khotaba S,Volfson M,Tarazova L,et al.Induction of labor in women with previous cesarean section using the double balloon device[J].Acta Obstet Gynecol Scand,2001,80(11):1041-1042.
[17]Atad J,Hallak M,Ben-David Y,et al.Ripening and dilatation of the unfavourable cervix for induction of labour by a double balloon device:experience with 250 cases[J].Br J Obstet Gynaecol,1997,104(1):29-32.
[18]崔金晖,滕奔琦,伍玲,等.宫颈扩张球囊与控释地诺前列酮栓用于足月妊娠促宫颈成熟的临床研究[J].中华围产医学杂志,2013,16(10):622-626.
[19]黄娟,王思义,陈颖,等.COOK双球囊促宫颈成熟的临床研究[J].中国计划生育和妇产科,2014,6(6):55-57.
[2]谢幸,苟文丽.妇产科学[M].8版.北京:人民卫生出版社,2013:187-189.
[3]范翠芳,孙艳梅,陈建华.双球囊在中晚期高危妊娠引产中应用的有效性及安全性[J].华中科技大学学报(医学版),2012,41(5):636-638.
[4]朱伟英,关怀,李小薇,等.双球囊导管促宫颈成熟及引产效果观察[J].人民军医,2014,57(10):1107-1110.
[5]郑剑兰,付景丽,张小琼,等.双球囊导管及0.8 mm控释地诺前列酮栓在促宫颈成熟与引产方面的随机对照研究[J].中华妇产科杂志,2011,46(8):610-612.
[6]中华医学会妇产科学分会产科学组.妊娠晚期促宫颈成熟与引产指南(2014)[J].中华妇产科杂志,2014,49(12):881-885.
[7]Miller NR,Cypher RL,Foglia LM,et al.Elective induction of labor compared with expectant management of nulliparous women at 39 weeks of gestation:a randomized controlled trial[J].Obstet Gynecol,2015,126(6):1258-1264.
[8]Anabusi S,Mei-Dan E,Hallak M,et al.Mechanical labor induction in the obese population:a secondary analysis of a prospective randomized trial[J].Arch Gynecol Obstet,2016,293(1):75-80.
[9]Prager M,Eneroth-Grimfors E,Edlund M,et al.A randomised controlled trial of intravaginal dinoprostone,intravaginal misoprostol and transcervical balloon catheter for labour induction[J].BJOG,2008,115(11):1443-1450.
[10]魏丽惠.妇产科诊疗常规[M].北京:中国医药科技出版社,2012:279.
[11]Ramirez MM.Labor induction:a review of current methods[J].Obstet Gynecol Clin North Am,2011,38(2):215-225.
[12]Romanelli M,Ribiani E,Burnelli L,et al.Pharmacological induction of labour:benefits and risks[J].Minerva Ginecol,2007,59(4):347-355.
[13]白桂芹,付逢萍,王慰敏.宫颈促成熟球囊在临床计划分娩中的作用[J].中国妇幼健康研究,2011,22(2):179-181.
[14]张建平,包琳.正确掌握引产催产方法[J].中国实用妇科与产科杂志,2012,28(2):89-93.
[15]Mukhopadhyay M,Lim KJ,Fairlie FM.Is propess a better method of induction of labour in nulliparous women[J].J Obstet Gynaecol,2002,22(3):294-295.
[16]Khotaba S,Volfson M,Tarazova L,et al.Induction of labor in women with previous cesarean section using the double balloon device[J].Acta Obstet Gynecol Scand,2001,80(11):1041-1042.
[17]Atad J,Hallak M,Ben-David Y,et al.Ripening and dilatation of the unfavourable cervix for induction of labour by a double balloon device:experience with 250 cases[J].Br J Obstet Gynaecol,1997,104(1):29-32.
[18]崔金晖,滕奔琦,伍玲,等.宫颈扩张球囊与控释地诺前列酮栓用于足月妊娠促宫颈成熟的临床研究[J].中华围产医学杂志,2013,16(10):622-626.
[19]黄娟,王思义,陈颖,等.COOK双球囊促宫颈成熟的临床研究[J].中国计划生育和妇产科,2014,6(6):55-57.