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临床试验/NCT06359886
NCT06359886招募中不适用

B-lynch Transverse Compression Suture in the Prophylaxis and Control of Postpartum Heamorrhage in Patients With Placenta Previa: A Pilot Study

Alexandria University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
Postoperative blood loss

研究概览

简要总结

Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa?

详细描述

To perform B-Lynch Transverse Compression Suture the investigators will use the suture material 1 Polyglactin 910 with a 70mm ½ circle needle mounted on a 90 cms suture. the investigators will use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle.

The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 1-3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side.

After encircling the para-uterine vasculature, the needle then perforates the posterior side of the uterus behind the vascular bundle entering the uterine cavity 1-3 cm below the inferior margin of the Caesarean incision. The suture can lie freely on the posterior wall of the uterine cavity and exists 3 cms above the upper margin of the Caesarean incision. It exits posteriorly and behind the vascular bundle to meet the suture from the other side.

It is essential that the ureters are identified by palpation or visual observation after the bladder is displaced inferiorly and held by traction. Any observed bleeding should be dealt with in the usual way. At the end of the suture application and before tying the knots, the lower segment is compressed again transversely whilst the suture is held taut to ensure that bleeding has ceased by swabbing the vagina again.

A wide pore drain will be inserted in the Douglas pouch, and the abdominal wall will be repaired.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • Single gestation
  • Elective CS for placenta preiva (diagnosed by transvaginal ultrasound).
  • Muliparity (para 2 or more).

排除标准

  • Morbidly adherent placenta: accrete, increta or percreta, diagnosed by abdominal and/or transvaginal ultrasound.
  • Ultrasonographic features of morbidly adherent placentas:
  • Loss of Retro-placental sonolucent zone.
  • Vascular lacunae.
  • Myometrial thinning.
  • Interruption of the bladder border.
  • More than 3 previous C.S.
  • Severely haemodynamic instablility needing immediate hysterectomy.
  • Patients with the cardiac, hepatic, renal or thromboembolic disease
  • Patients with coagulopathy:
  • Receiving anticoagulant therapy.
  • With thrombocytopenia or thrombasthenia.
  • Known coagulation factor defect.
  • Distorted uterus as unicornuate, bicornuate, fibroid uterus and adenomyosis uteri.

结局指标

主要结局

Postoperative blood loss

时间窗: 2 days following the procedure

Postoperative blood loss in the drain bag

Number of received blood components

时间窗: 2 days following the procedure

Packed RBC's

Peripartum haemoglobin level drop

时间窗: 2 days following the procedure

Difference between pre and postoperative hemoglobin level

Intraoperative blood loss

时间窗: 2 days following the procedure

Number of towels and blood in suction reservoir

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Zeerban

Doctor

Alexandria University

研究点 (2)

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