胎盘植入病例剖宫产术的麻醉管理：腹主动脉球囊阻断与未阻断的比较：一项随机对照试验的研究方案
Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial.
作者信息
Chu Qinjun, Shen Dan, He Long, Wang Hongwei, Zhao Xianlan, Chen Zhimin, Wang Yanli, Zhang Wei
机构信息
Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Jian She Dong Lu, No 1, Zhengzhou, 450052, Henan Province, China.
Department of Obstetrics, The First Affiliated Hospital of Zhengzhou University, Jian She Dong Lu, No 1, Zhengzhou, 450052, Henan Province, China.
出版信息
Trials. 2017 May 26;18(1):240. doi: 10.1186/s13063-017-1977-5.
BACKGROUND
Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others. However, up to now, all studies on AABO were almost retrospective. Current evidence is insufficient to recommend for or against routinely using the AABO technology for control intraoperative hemorrhage in patients with PA. Thus, we hope to carry out a prospective, randomized controlled trial (RCT) study to confirm the effectiveness of the AABO technology in patients with PA.
METHODS/DESIGN: This trial is an investigator-initiated, prospective RCT that will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. A total of 170 parturients with PA undergoing cesarean section will be randomized to receive either AABO in combination with cesarean section or the traditional hysterectomy following cesarean section. The primary outcome is estimated blood loss. The most important secondary outcome is the occurrence of cesarean hysterectomy during delivery; others include blood transfusion volume, operating time, neonate's Apgar scores (collected at 1, 5 and 10 min), length of stay in intensive care unit, total hospital stay, and balloon occlusion-relative data.
DISCUSSION
This prospective trial will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. It may provide strong evidence about the benefits and risks of AABO in combination with cesarean section for parturients with PA.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR-INR-16008842 . Registered on 14 July 2016.
背景
胎盘植入（PA）是分娩期间的一种严重并发症，与可能危及母婴生命的大出血密切相关。此外，在过去几十年中，随着剖宫产率的上升，PA的发病率急剧增加。因此，有必要开展研究来评估基于不同方式的围手术期管理在PA治疗中的效果。在众多治疗措施中，预防性腹主动脉球囊阻断术（AABO）联合剖宫产治疗PA似乎比其他方法更具优势。然而，截至目前，所有关于AABO的研究几乎都是回顾性的。目前的证据不足以推荐或反对常规使用AABO技术来控制PA患者术中出血。因此，我们希望开展一项前瞻性随机对照试验（RCT）研究，以证实AABO技术对PA患者的有效性。
方法/设计：本试验是一项由研究者发起的前瞻性RCT，将测试AABO联合剖宫产相对于传统剖宫产术后子宫切除术对PA产妇的优越性。总共170例接受剖宫产的PA产妇将被随机分组，分别接受AABO联合剖宫产或传统剖宫产术后子宫切除术。主要结局指标是估计失血量。最重要的次要结局指标是分娩期间剖宫产子宫切除术的发生率；其他指标包括输血量、手术时间、新生儿Apgar评分（分别在1分钟、5分钟和10分钟收集）、重症监护病房住院时间、总住院时间以及球囊阻断相关数据。
讨论
这项前瞻性试验将测试AABO联合剖宫产相对于传统剖宫产术后子宫切除术对PA产妇的优越性。它可能为AABO联合剖宫产对PA产妇的益处和风险提供有力证据。
试验注册
中国临床试验注册中心，ChiCTR-INR-16008842。于2016年7月14日注册。
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