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

Trans-cervicai Foley catheter balloon versus vaginal prostaglandin E2 suppository for cervical ripening and induction of labor： a prospective randomized controlled trial

目的比较Foley尿管水囊与普贝生栓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2009年6月至12月在本院待产的孕足月、单胎头位、有引产指征、阴道清洁度≤Ⅱ度、胎膜完整、宫颈Bishop评分〈6分的初产妇，签署随机对照研究知情同意书后，随机分为2组，最终纳入分析的共126例，分别予Foley尿管水囊（64例）和普贝生栓（62例）促宫颈成熟，Foley尿管水囊组与普贝生栓组孕妇的孕周、引产前宫颈评分、引产指征差异无统计学意义。采用t、χ2检验或Fisher精确概率法比较2组孕妇的引产成功率、分娩方式、产程时间及母儿结局。结果Foley尿管水囊组与普贝生栓组宫颈评分改善、引产成功率、阴道分娩率、总产程、产后出血量差异均无统计学意义（P〉0．05）。Foley尿管水囊组较普贝生栓组引产24h内阴道分娩率低[28．1％（18／64）与56．5％（35／62），t=10．37，P〈0．05]，宫缩过频过强发生率也较低E0．0％（0／64）与17．7％（11／62），P〈0．05]，但缩宫素使用率高E87．5％（56／64）与21．0％（13／62），χ2=56．27，P〈0．05]。2组新生儿Apgar评分、羊水胎粪污染发生率、新生儿体重差异均无统计学意义（P〉0．05）。2组孕妇无一例发生产褥感染。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。

Objective To compare the effectiveness and safety of Foley catheter （FC） and vaginal prostaglandin E2 suppository （PGE2, Propess） for cervical ripening and labor induction in fullterm pregnant women with unfavorable cervix. Methods A prospective randomized controlled trial was conducted. Women with a term or post-term, live, singleton fetus in cephalic presentation, intact membranes, Bishop score〈6, not in labor, medically indicated for labor induction from June 2009 to December 2009 in Drum Tower Hospital of Nanjing University Medical School were randomly divided into two groups： FC group （n=64） and Propess group （n=62）. In FC group, a 16-F Foley catheter was inserted into patient＇s cervical canal; once past the internal os, the balloon was inflated with 80 ml saline. Intravenous oxytocin was initiated after the balloon was spontaneously extruded from the cervix or after 24 hours. In Propess group, vaginal Propess was used. χ2 or Fisher＇s exact test and t test were used to compare the outcomes, delivery mode and induction success rate between the two groups. Results There were no significant differences in gestational weeks, Bishop score, indication of induction, improvement of Bishop score, success rate of induction, rate of vaginal delivery, total duration of labor and volume of postpartum hemorrhage between the two groups （P 〉0.05, respectively）. Propess group had a higher rate of vaginal birth within 24 hours [56.5% （35/62） vs 28.1% （18/64）, t=10.37, P〈0.05], a higher risk for excessively frequent and hard uterine contraction [17.7% （11/62） vs 0.0% （0/64）, P〈0.05] and lower incidence of oxytocin induction/augmentation during labor [21.0% （13/62） vs 87.5% （56/64）,χ2 =56.27,P〈0.05] than those of FC group. There were no differences in neonatal Apgar score, meconiurn staining and neonatal birth weight between the two groups. Puerperal infection occured in neither group. Conclusions Under strict control of indication and aseptic manipulation, Foley catheter was as effective and safe as Propess for cervical ripening with lower risk of excessive uterine activity. It is suggested that Foley catheter could be used for cervical ripening, especially in patients with economic difficulty.