跳至主要内容
临床试验/NCT04423263
NCT04423263Unknown不适用

Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial

Voon Hian Yan0 个研究点目标入组 24 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
24
主要终点
Pack cell transfusion

研究概览

简要总结

This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac artery occlusion performed prior to planned surgical management for placenta accreta spectrum (PAS). The intervention group would receive balloon occlusion, ureteric stenting and caesaeran hysterectomy while the control group would undergo the same procedure, excluding balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in pack cell transfusion requirement.

详细描述

Interventional radiology, including internal iliac artery occlusion, has been used as an adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have shown benefit in terms of reduction of blood loss. However, studies reported in literature vary widely in terms of the exact surgical procedure undertaken, in conjunction with the radiological intervention. The radiological intervention itself lacks standardization, occurring at different anatomical levels, ranging from infrarenal aortic occlusion to internal iliac or uterine artery. Furthermore, there have been reported cases of arterial thrombosis associated with arterial occlusion.

We sought to clarify the effectiveness of a standardized approach , where perioperative bilateral internal iliac artery occlusion is performed followed by bilateral ureteric stenting and caesarean hysterectomy. The control group would undergo the exact procedure, excluding internal iliac artery occlusion. Patients would be randomized but neither the patient nor surgeon could be blinded.

The primary outcome would be to demonstrate a three pint or greater reduction in packed cell transfusion. Secondary outcomes include a difference in estimated blood loss, additional blood product transfusion, unplanned additional surgical procedure, serious complications arising from internal iliac artery occlusion, total procedural time and early neonatal outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All pregnant women with prenatally diagnosed placenta accreta spectrum

排除标准

  • Women who declined to participate
  • Women with bleeding diathesis or severe thrombocytopenia <100k x 1,000,000/L
  • Surgery performed prior to 28 weeks of gestation

结局指标

主要结局

Pack cell transfusion

时间窗: First 7 days post-operatively

To detect a three pint reduction in pack cell transfusion

次要结局

  • Complication from internal iliac occlusion(First 14 days post-operatively)
  • Other blood components(First 7 days post-operatively)
  • Unplanned perioperative surgical procedures(First 7 days post-operatively)

研究者

发起方
Voon Hian Yan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Voon Hian Yan

Consultant Maternal Fetal Medicine Specialist

Sarawak General Hospital

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