Departments of Obstetrics and Gynecology, Ultrasound, Radiology, and Pathology and the Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, West China Second University Hospital of Sichuan University, Chengdu, China.
Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.
To investigate the effect of intraoperative balloon occlusion of the internal iliac arteries in women with placenta previa and antenatally diagnosed placenta accreta.
In this single-center, randomized controlled trial, women with placenta previa and antenatally suspected placenta accreta were randomly assigned to either the balloon occlusion group or to the control group. The perioperative management approach was similar for both groups, other than preoperative balloon catheter placement and intraoperative occlusion of bilateral internal iliac arteries. The primary outcome was the number of packed red blood cell (RBC) units transfused. With a two-sided α of 0.05 and a power of 0.8, a sample size of 48 women per group was calculated to detect a mean reduction of 2 units packed RBCs transfused with an expected SD of 3.5.
From August 2017 to July 2018, we randomized 50 eligible women to the balloon group and 50 to the control group. Demographic, obstetric, and placental imaging characteristics were similar between groups. The number of packed RBC units transfused was not significantly different between groups (5.3±5.3 in the occlusion group vs 4.7±5.4 in the control group, P=.54). Hospitalization costs and incidence of postoperative fever were significantly higher in the balloon group. No significant differences were found in other outcomes.
Intraoperative balloon occlusion of the internal iliac arteries did not reduce the number of packed RBC units transfused in women with placenta previa and antenatally suspected placenta accreta.
Chinese Clinical Trial Registry, ChiCTR-IOR-17012244.
探讨术中球囊阻断髂内动脉对前置胎盘合并产前诊断胎盘植入妇女的影响。
在这项单中心、随机对照试验中，将前置胎盘且产前疑似胎盘植入的妇女随机分为球囊阻断组或对照组。两组的围手术期处理方法相似，除了术前放置球囊导管和术中阻断双侧髂内动脉。主要结局是输血量（以单位红细胞悬液计）。双侧α值为 0.05，效能为 0.8，计算出每组需要 48 名妇女，以检测预期标准差为 3.5 时，平均减少 2 单位输血量。
2017 年 8 月至 2018 年 7 月，我们将 50 名符合条件的妇女随机分配至球囊组和对照组。两组的人口统计学、产科和胎盘成像特征相似。输血量无明显差异（球囊组 5.3±5.3 单位 vs 对照组 4.7±5.4 单位，P=.54）。球囊组的住院费用和术后发热发生率显著较高。其他结局无显著差异。
对于前置胎盘合并产前疑似胎盘植入的妇女，术中球囊阻断髂内动脉并未减少输血量。
中国临床试验注册中心，ChiCTR-IOR-17012244。
