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临床试验/NCT03707132
NCT03707132已完成不适用

Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold

University Tunis El Manar0 个研究点目标入组 43 人开始时间: 2014年10月1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
43
主要终点
Estimated blood loss

研究概览

简要总结

Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta

详细描述

It is a monocentric prospective observational case-control study in the Department "C" of Gynecology and Obstetrics in the Maternity and Neonatology Center of Tunis during three years from October 2014 to September 2017.

All parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. After obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. Either it was highly suspected or confirmed by obstetrical imaging. MRI was always performed in cases of scheduled cesarean delivery. However, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. Delivery was usually scheduled at 36 weeks of gestation.

Patients were allocated into two group: Group TG in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group CG when the emergent caesarian hysterectomy was performed without a tourniquet. Allocation depended on the technique and the decision of the surgeon in charge.

After appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. The laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. Hysterotomy was made far from the placental insertion which was previously located by ultrasonography. The accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. The umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. Careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. Tourniquet application procedure is described as following

  1. Suturing hysterotomy with placenta kept in place.
  2. After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet.
  3. complete hysterectomy

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • . All patients undergoing scheduled or emergency cesarean section for placenta accreta

排除标准

  • No signs of accretetization upon artificial delivery

结局指标

主要结局

Estimated blood loss

时间窗: peroperatively

Blood spoliation during procedure

Hemoglobin variation

时间窗: First 24 hours

the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure

Transfusion requirements

时间窗: First 24 hours

Number of red blood cells units transfused

procedure duration

时间窗: peroperatively

Time needed to perform hysterectomy from incision to skin closure

Intensive care transfer rate

时间窗: first 24 hours

Intensive care transfer following hysterectomy for placenta accreta

次要结局

  • length of stay in ICU(time from surgery up to 30 days postoperative)
  • clotting disorders(time from surgery up to 30 days postoperative)
  • Bladder wound(time from surgery up to 30 days postoperative)
  • Digestive wound(time from surgery up to 30 days postoperative)

研究者

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

Ben marzouk Sofiene

clinical associate professor

University Tunis El Manar

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