宫颈扩张球囊伴随与不伴随缩宫素促宫颈成熟的对照研究

Contrast study of double-balloon catheter with and without oxytocin for cervical ripening

目的探讨宫颈扩张球囊伴随与不伴随缩宫素促宫颈成熟的有效性及其相关问题。方法本研究为前瞻性非随机对照研究，对2015年3月至2017年6月在清华大学玉泉医院分娩的初产妇，具备引产指征、符合球囊放置条件者分为两组，其中球囊＋缩官素组78例：球囊放置1h无宫缩，开始静脉滴注缩宫素。球囊组220例。比较两组产妇球囊放置前、取出后宫颈Bishop评分变化以及分娩结局。结果球囊＋缩宫素组促宫颈成熟的有效率、12h内临产率均高于球囊组，两组的有效率分别是[92．3％（72／78）和82．7％（182／220），P〈0．05]，12h内临产率分别是[15．4％（12／78）和7．3％（16／220），P〈0．05]。球囊＋缩宫素组宫颈Bishop评分4～5分产妇促宫颈成熟的有效率进一步提高（P〈0．05），两组分别是95．7％（66／69）和85．1％（165／194）。球囊＋缩宫素组球囊取出当时宫颈Bishop评分（8．1±1．1）分高于球囊组（6．5±1．2）分（P〈0．05）。球囊＋缩宫素组取出球囊12h未临产的产妇，宫颈Bishop评分由（7，7±0．9）分下降到（6．6±0．6）分（P〈0．05）。球囊＋缩宫素组以宫内感染为指征的剖宫产高于球囊组（P〈0．05），最终胎盘病理诊断宫内感染者差异无统计学意义（P〉0．05）。两组产妇的剖宫产率、第一产程时间、会阴侧切率、产后出血率、新生儿体质量、新生儿窒息及转诊率的比较差异均无统计学意义（均P〉0．05）。结论官颈扩张球囊伴随缩宫素可以进一步提高宫颈Bishop评分4—5分产妇促宫颈成熟的有效率，增加12h内的临产机会。

Objective To evaluate the efficacy and related issues for cervical ripening by double- balloon catheter with and without oxytocin. Methods The prospective non-randomly control research was conducted from March 2015 to June 2017 in Yuquan Hospital of Tsinghua University. The primipara with induced labor indications and balloon placement conditions were divided into two groups. Seventy-eight cases were in the balloon with oxytoein group, in which oxytocin was used if there were no contraction 1 hour after balloon placement. Meanwhile, 220 cases were in the single balloon group. Before and after balloon placement, the changes of cervical Bishop Scores and delivery outcome were compared between the groups. Results The effective rate of cervical ripening in the balloon with oxytocin group was higher than that in the balloon group [ 92. 3 % （ 72/78 ） vs 82. 7 % （182/220） , P 〈 0. 05 ] , the proportion of parturiency within 12 hours was as well[ 15.4% （12/78） vs 7.3% （16/220）, P 〈 0. 05 ]. The effective rate of cervical Bishop score 4- 5 points was further improved in the balloon with oxytoein group [ 95.7% （66/69） vs 85.1% （165/194） , P 〈 0.05 ]. Taken out balloon, the cervical Bishop scores （8.1 ± 1.1 ） points in the balloon with oxytoein group were higher than （6. 5± 1.2） points in the balloon group （ P 〈 0. 05 ）. For the maternal without parturiency in the balloon with oxytocin group, the cervical Bishop score reduced from （7.7 ±0. 9 ） points to （6. 6 ±0. 6） points after removal balloon for 12 hours （P 〈0. 05）. The cesarean section proportion for intrauterine infection in the balloon with oxytocin group was higher than that of the balloon group （ P 〈 0. 05 ） , but the placental pathological diagnosis proportion was no significant difference （ P 〉 0.05 ）. In the two groups, the cesarean section rate, the first labor stage, the episiotomy rate, the postpartum hemorrhage rate, neonatal weight, the neonatal asphyxia and referral rate showed no significant differences （ P 〉 0. 05,respectively）. Conclusions The double-balloon catheter with oxytocin can further improve the efficiency of patients with cervical Bishop score 4 - 5 points for cervical ripening , and increase the chance of labor in 12 hours.