宫颈扩张单球囊及双球囊促宫颈成熟临床观察

目的 探讨宫颈扩张单球囊及双球囊在改善宫颈条件的效果及安全性。方法 本研究应用前瞻性随机对照研究，选取因妊娠并发症或合并症或延期妊娠而需要引产的足月单胎产妇323例为观察对象。随机分为宫颈扩张单球囊组（A组，n=162例）和宫颈扩张双球囊组（B组，n=161例）。比较两组产妇应用宫颈扩张球囊后子宫颈改善的有效性及不良反应的发生情况。结果 两组宫颈Bishop评分改善有效率差异无统计学意义，分别为99.4%（161/162）和97.5%（157/161）（P>0.05）。A组自然临产率较B组高，分别为55.6%（90/162）和34.2%（55/161）（P<0.05）；球囊放置至活跃期时间，分别为16.4±5.3和17.0±5.3h，球囊放置至分娩时间分别为18.3±5.5和19.2±6.0h，两组比较差异均无统计学意义（P>0.05）；A组剖宫产率低于B组，分别为11.1%（18/162）和19.9%（32/161），两组比较差异有统计学意义（P<0.05）；宫内感染分别为10.7%（17/159）和16.8%（26/155）、新生儿窒息分别为2.5%（4/159）和1.3%（2/155）、脐带脱垂发生率分别为0.6%（1/162）和0（0/161）、产后出血量分别为100（50~1300）和100（50~650）ml，两组间比较差异无统计学意义（P均>0.05）。结论 宫颈扩张单球囊及双球囊均能有效促宫颈成熟。宫颈扩张单球囊有着较高的自然临产率，较低的剖宫产率，更适用于临床促宫颈成熟。

Single-balloon Compared with Double-balloon Catheters for Cervical Ripening: A Clinical Trial

Objective To evaluate the efficacy and safety for cervical ripening by single-balloon and double-balloon catheters among full-term pregnancy women underwent labor induction. Methods Totally 323 singleton-pregnancy women in full-term who had to undergo labor induction because of pregnancy complications, comorbitities or delayed pregnancy were selected as study subjects. They were randomly divided into two groups: 162 women in single-balloon group (Group A) and 161 in double-balloon catheters (Group B). The efficacy and safety for cervical ripening in two groups were compared. Results The efficacy for cervical ripening had no significant differences between two groups [99.4% (161/162) vs 97.5% (157/161), P>0.05]. The rate of natural labor was significantly higher in Group A than B [55.6%(90/162) vs 34.2%(55/161), P<0.05]. There were no significant differences in time interval between catheter inserting and active stage of labor [16.4±5.3 vs 17.0±5.3h], time interval between catheter inserting and deliver [18.3±5.5 vs 19.2±6.0h] between the two groups, P>0.05. The cesarean section rate in Group A was lower than B [11.1%(18/162) vs 19.9%(32/161), P<0.05]. There were no significant differences of the intrauterine infection demonstrated by clinical diagnosis [10.7%(17/159) vs 16.8%(26/155)], asphyxia neonatorum [2.5%(4/159) vs 1.3%(2/155)], umbilical cord prolapse [0.6%(1/162) vs 0.0%(0/161)], postpartum hemorrhage volume [100(50-1300) vs 100(50-650)ml]between the two groups, P>0.05. Conclusion Both single-balloon catheter and double-balloon catheters can improve the cervical ripening. Compared with double-balloon catheters, the single-balloon catheter was more suitable for ripening the cervical in clinic because of having lower cesarean section rate and with more women in spontaneous labor.