Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.
Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.
Am J Obstet Gynecol. 2020 Jul;223(1):117.e1-117.e13. doi: 10.1016/j.ajog.2020.01.024. Epub 2020 Jan 21.
Placenta previa remains one of the major causes of massive postpartum hemorrhage and maternal mortality worldwide.
To determine whether internal iliac artery balloon occlusion during cesarean delivery for placenta previa could reduce postpartum hemorrhage and other maternal complications.
This was a prospective randomized controlled trial conducted at a tertiary university obstetric unit in Hong Kong. Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2 cm from the internal os) and required cesarean delivery were invited to participate. Eligible pregnant women were randomized into internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group. Those randomized to the Occlusion group had internal iliac artery balloon catheter placement performed before cesarean delivery and then balloon inflation after delivery of the baby. The primary outcome was the reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion. Secondary outcome measures included hemoglobin drop after delivery; amount of blood product transfusion; incidence of hysterectomy; maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, and adult respiratory distress syndrome; length of stay in hospital; admission to intensive care unit; and maternal death.
Between May 2016 and September 2018, 40 women were randomized (20 in each group). Demographic and obstetric characteristics were similar between the 2 groups. In the Occlusion group, 3 women did not receive the scheduled procedure, as it was preceded by antepartum hemorrhage that required emergency cesarean delivery, and 1 woman had repeated scan at 36 weeks showing the placental edge was slightly more than 2 cm from the internal os. Intention-to-treat analysis found no significant differences between the Occlusion and the Control groups regarding to the median intraoperative blood loss (1451 [1024-2388] mL vs 1454 [888-2300] mL; P = .945), the median length of surgery (49 [30-62] min vs 37 [30-51] min; P = .204), or the need for blood transfusion during operation (57.9% vs 50.0%; P = .621). None of the patients had rebleeding after operation, complication related to internal iliac artery procedure, or any other maternal complications. Reanalyzing the data using on-treatment approach showed the same results.
The use of prophylactic internal iliac artery balloon occlusion in placenta previa patients undergoing cesarean delivery did not reduce postpartum hemorrhage or have any effect on maternal or neonatal morbidity.
前置胎盘仍然是全球产后大出血和产妇死亡的主要原因之一。
确定剖宫产术中使用髂内动脉球囊闭塞术是否可以减少产后出血和其他产妇并发症。
这是一项在香港一所三级大学妇产科进行的前瞻性随机对照试验。邀请在 34 周时被诊断为前置胎盘（定义为胎盘下缘距宫颈内口 2cm 以内）且需要剖宫产的孕妇参与。符合条件的孕妇被随机分为髂内动脉球囊闭塞（闭塞）组或标准治疗（对照）组。随机分至闭塞组的孕妇在剖宫产前行髂内动脉球囊导管放置，然后在婴儿娩出后进行球囊充气。主要结局是使用髂内动脉球囊闭塞术减少产后出血。次要结局包括产后血红蛋白下降；输血量；子宫切除术的发生率；产妇并发症，包括肾衰竭、缺血性肝、弥漫性血管内凝血和成人呼吸窘迫综合征；住院时间；入住重症监护病房；以及产妇死亡。
2016 年 5 月至 2018 年 9 月期间，共有 40 名孕妇被随机分组（每组 20 名）。两组的人口统计学和产科特征相似。在闭塞组中，有 3 名妇女因产前出血需要紧急剖宫产而未接受预定手术，1 名妇女在 36 周时再次扫描显示胎盘边缘距离宫颈内口略超过 2cm。意向治疗分析发现，闭塞组与对照组术中中位失血量（1451[1024-2388]ml 比 1454[888-2300]ml；P=.945）、手术中位时间（49[30-62]min 比 37[30-51]min；P=.204）或术中输血需求（57.9%比 50.0%；P=.621）均无显著差异。术后无患者再次出血、与髂内动脉操作相关的并发症或其他任何产妇并发症。采用治疗方法重新分析数据，结果相同。
在剖宫产术中预防性使用髂内动脉球囊闭塞术并不能减少产后出血，也不能降低产妇或新生儿的发病率。
