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临床试验/NCT06356493
NCT06356493已完成不适用

Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for Placenta Accreta Spectrum Disorder Reduces Blood Loss: a Retrospective Comparative Study

Tunis University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Postoperative transfer to the intensive care unit

研究概览

简要总结

The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.

The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders.

详细描述

Study population:

In the study, the population was divided into two groups:

Group1: Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries.

Group2: Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries.

Service Protocol:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • placenta accreta spectrum disorder (PASD) confirmed by histopathological examination.
  • caesarean hysterectomy.

排除标准

  • placenta accreta suspected in MRI fundings but disproved in in histopathological examination.
  • conservative treatment of PASD

结局指标

主要结局

Postoperative transfer to the intensive care unit

时间窗: up to 40 days postpartum

NUMBER

calculated blood loss

时间窗: peroperatively

The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding

Duration of surgery

时间窗: peroperatively

MINUTES

Postoperative hospital stay

时间窗: up to 40 days postpartum

DAYS

Transfusion peroperatively

时间窗: First 24 hours]

peroperatively

次要结局

  • Morbidity(time from surgery up to 30 days postoperative)

研究者

发起方
Tunis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haithem Aloui

university hospital assistant

Tunis University

研究点 (1)

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