B-lynch Transverse Compression Suture in the Prophylaxis and Control of Postpartum Heamorrhage in Patients With Placenta Previa: A Pilot Study
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
- 否
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
Ahmed Zeerban
Doctor
Alexandria University
