普贝生栓与Foley尿管水囊促宫颈成熟用于足月妊娠引产的前瞻性随机对照研究

摘要

Objective To compare the effectiveness and safety of Foley catheter (FC) balloon and vaginal prostaglan-din E2 suppository (Propess) for cervical ripening and labor induction in full-term pregnant women with unfavorable cervix. Methods A prospective randomized controlled trial was conducted. The primiparas with term - pregnancy, singleton fetus in cephalic presentation, intact membranes, Bishop score < 6, medically indicated for labor induction from January to December 2010 in Xinjiang were randomly divided into two groups: Propess group (n = 124) and FC group (n = 128). The pregnant women in the two groups showed no statistically differences in gestational weeks, cervical score before labor induction, and induced labor indications (P >0. 05). The t test and X2 or Fisher's exact test were used to compare the induction success rate, delivery mode, labor time, and maternal and neonatal outcomes between the two groups. Results There were no significant differences in Bishop score, success rate of induction, delivery mode, total duration of vaginal delivery, and volume of postpartum hemorrhage between the two groups (P >0. 05). However, compared with the FC group, in the Propess group the rate of vaginal delivery within 24 hours was lower, the times from induction to labor and from induction to delivery were longer, and the utilization rate of Ox-ytocin was higher, with significant differences (P <0. 05). No puerperal infection occurred in patients of both groups. Conclusion Under strict control of indication and aseptic manipulation, Foley catheter can get the similar efficacy and maternal - neonatal outcomes of induction with Propess for cervical ripening and induction of labor, and no over frequent and over intensive uterine contraction was found, so it is of such advantages as high security and lower cost.%目的 比较普贝生栓与Foley尿管水囊促宫颈成熟用于足月妊娠引产的安全性和有效性.方法 采用前瞻性随机对照研究方法,选择2010年1-12月在新疆本地待产的孕足月、单胎头位、有引产指征、胎膜完整、宫颈Bishop评分＜6分的初产妇,随机分为普贝生栓组(124例)和Foley尿管水囊组(128例)促宫颈成熟,两组孕妇的孕周、引产前宫颈评分、引产指征差异均无统计学意义(P＞0.05).采用t、χ2检验或Fisher精确概率法比较两组孕妇的引产成功率、分娩方式、产程时间及母婴结局.结果 两组宫颈Bishop评分、引产成功率、分娩方式、阴道分娩总产程、产后出血量、剖宫产指征以及新生儿出生体质量、羊水胎粪污染率间差异均无统计学意义(P＞0.05).但Foley尿管水囊组较普贝生栓组24 h内阴道分娩率低,引产至临产时间及引产至分娩时间长,缩宫素使用率高,差异有统计学意义(P＜0.05).两组孕妇均未发生产褥感染.结论 严格掌握Foley尿管水囊促宫颈成熟的指征及执行无菌操作规程,可以取得与普贝生栓相似的促宫颈成熟效果及引产母婴结局,未发生过频过强宫缩,具有安全性高及成本低廉等优点.