Objective: To access the effectiveness and safety of the intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion in the management of placenta accreta spectrum (PAS). Methods: This was an open-label, randomized controlled trial conducted in Nanjing Drum Tower Hospital. The patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018. When bleeding could not be achieved after fetus delivered, and a temporary abdominal aortic balloon occlusion and the compression sutures as needed, the women were randomly allocated 1∶1 into balloon tamponade (n=81) or gauze packing (n=80) group. The primary outcome was successful bleeding arrests by avoiding second line surgeries. The secondary outcomes included the volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications. Results: All the women [100% (81/81)] in the balloon group were obtained hemostasis without further intervention, significantly higher than 88% (70/80) in the gauze group (P=0.001). Before uterine tamponade, blood loss were 820 ml (620-1 230) ml and 850 ml (605-1 442) ml, while placenta bed were sutured in 96%（78/81, 77/80） respectively (P>0.05).The proportion of blood loss≥1 000 ml was higher in the gauze group than that in the balloon group (P=0.006). Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain occurred more frequently in the gauze group (P<0.05). The following outcome showed no statistically significant difference between the two groups: the vascular occlusion time, the dose of radiation, and interventional radiology complication (P>0.05). The median volume infused into the lower and upper balloons is 70 ml (50-100 ml) and 180 ml (100-240 ml). Conclusions: Incrauterine balloon tamponade is as effective as gauze packing in hemostasis following the placenta delivery in PAS. Compared with gauze packing, the uterine balloon tamponade is more effective.
目的： 评价宫腔止血囊联合腹主动脉临时阻断术用于胎盘植入性疾病（PAS）剖宫产术中止血的有效性和安全性。 方法： 收集2015年8月至2018年1月在南京大学医学院附属鼓楼医院收治的疑为PAS计划保留子宫的孕妇。胎儿娩出后以腹主动脉球囊临时阻断以及必要时胎盘附着部位压迫缝合术等处理仍不能止血时，根据随机表按1∶1将孕妇分为止血囊组（n=81）和纱条组（n=80），进行开放的随机对照研究。比较两组产妇的主要结局指标止血成功率，次要结局指标剖宫产术围术期的出血量和出血率，以及输血、子宫切除、术后疼痛、ICU入住、住院时间、再入院和放射介入相关并发症。 结果： 止血囊组的止血成功率为100%（81/81），显著高于纱条组的88%（70/80；P=0.001）。宫腔填塞之前，止血囊组、纱条组产妇的中位出血量分别为820 ml （620~1 230 ml）和850 ml（605~1 442 ml），进行子宫下段局部压迫缝合术的比例均为96%（78/81和77/80），两组分别比较，差异均无统计学意义（P>0.05）。但填塞后出血量纱条组显著高于止血囊组（P<0.01）；纱条组产后出血≥1 000 ml者占69%（55/80），也明显多于止血囊组的47%（38/81；P=0.006）。纱条组其他结局指标，包括产后贫血，产褥病率和术后疼痛评分均高于止血囊组。止血囊组和纱条组的动脉阻断时长、放射剂量、动脉临时阻断相关并发症发生率两组分别比较，差异均无统计学意义（P>0.05）。宫腔止血囊上囊中位数注水量为180 ml（100~240 ml），下囊为70 ml（50~100 ml），无止血囊相关严重并发症发生。 结论： 在PAS剖宫产术中，止血囊和纱条宫腔填塞都能有效用于胎盘娩出后的止血，但宫腔止血囊比纱条止血效果更好，并发症少。取出宫腔纱条时，要做好防治大出血的准备。.
Keywords: Cesarean section; Endotamponade; Hemostatic techniques; Intrauterine balloon tamponade; Placenta Accreta; Placenta previa.