Meng Chen1, Xinghui Liu, Yong You, Xiaodong Wang, Tao Li, Hong Luo, Haibo Qu, Lian Xu. 1. 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.
Abstract
OBJECTIVE: To investigate the effect of intraoperative balloon occlusion of the internal iliac arteries in women with placenta previa and antenatally diagnosed placenta accreta. METHODS: 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. RESULTS: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. CONCLUSION: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. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-17012244.
RCT Entities:
OBJECTIVE: To investigate the effect of intraoperative balloon occlusion of the internal iliac arteries in women with placenta previa and antenatally diagnosed placenta accreta. METHODS: 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. RESULTS: 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. CONCLUSION: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. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-17012244.