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主动脉球囊阻断术在前置胎盘谱系疾病剖宫产术中减少失血的有效性:一项随机对照试验的研究方案

Effectiveness of aortic balloon occlusion in reducing blood loss during cesarean section in placenta accreta spectrum disorders: a study protocol for a randomized controlled trial.

作者信息

Bapayeva Gauri, Aimagambetova Gulzhanat, Kadroldinova Nazira, Zemlyanskiy Viktor, Kassymbek Kuat, Terzic Milan

机构信息

Clinical Academic Department of Women's Health, CF "University Medical Center", Astana, Kazakhstan.

Department of Surgery, School of Medicine, Nazarbayev University, Astana, Kazakhstan.

出版信息

Front Med (Lausanne). 2025 Feb 24;12:1535258. doi: 10.3389/fmed.2025.1535258. eCollection 2025.

Abstract

INTRODUCTION

Obstetric hemorrhage is one of the leading causes of maternal mortality and morbidity worldwide. One of the major risk factors of obstetric hemorrhage include placenta previa and placenta accreta spectrum (PAS) disorders. The frequency of PAS disorders is increasing worldwide and is accompanied by massive intraoperative bleeding with hemorrhagic shock and increasing rates of cesarean hysterectomy. To decrease the risks of bleeding, various approaches to endovascular balloon occlusion have been tested during the past decade.

OBJECTIVES

This study aimed to evaluate the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) in reducing blood loss and preserving the reproductive organs during cesarean section. Study design: This will be a prospective randomized controlled trial involving 144 patients in a tertiary care obstetric center in Kazakhstan. The study population will consist of pregnant women who will be admitted for cesarean section due to placenta previa complicated by PAS disorders. The study subjects will be randomly divided into intervention and control groups.

RESULTS

The results will be analyzed through the measurement of primary (blood loss during cesarean section) and secondary outcomes [occurrence of hysterectomy during cesarean section, blood transfusion volume, duration of surgery, balloon application time, stay in intensive care unit (ICU), neonatal outcomes, complications, and total days of postsurgical hospital stay].

CONCLUSION

The use of REBOA is expected to minimize intraoperative blood loss during cesarean section, decrease the need for transfusion of blood components, reduce the time of surgical intervention, decrease the rate of maternal complications, and reduce the rate of cesarean hysterectomy.

摘要

引言

产科出血是全球孕产妇死亡和发病的主要原因之一。产科出血的主要危险因素之一包括前置胎盘和胎盘植入谱系(PAS)疾病。PAS疾病在全球范围内的发病率正在上升,并伴有术中大量出血、失血性休克以及剖宫产子宫切除术发生率的增加。为降低出血风险,在过去十年中对各种血管内球囊阻断方法进行了测试。

目的

本研究旨在评估复苏性主动脉内球囊阻断术(REBOA)在剖宫产术中减少失血和保留生殖器官方面的有效性。研究设计:这将是一项前瞻性随机对照试验,涉及哈萨克斯坦一家三级医疗产科中心的144名患者。研究人群将包括因前置胎盘合并PAS疾病而入院接受剖宫产的孕妇。研究对象将被随机分为干预组和对照组。

结果

将通过测量主要结局(剖宫产术中的失血量)和次要结局[剖宫产术中子宫切除术的发生率、输血量、手术持续时间、球囊应用时间、重症监护病房(ICU)住院时间、新生儿结局、并发症以及术后住院总天数]来分析结果。

结论

预计使用REBOA可使剖宫产术中的术中失血量降至最低,减少血液成分输血需求,缩短手术干预时间,降低孕产妇并发症发生率,并降低剖宫产子宫切除术的发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b93/11891061/ce7654303bfb/fmed-12-1535258-g001.jpg

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