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临床试验/NCT04193618
NCT04193618已完成不适用

Conservative Surgery for Abnormally Invasive Placenta: A New Technique

Cairo University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
intraoperative blood loss

研究概览

简要总结

Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively .

bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta

*Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .

Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .

Then we proceed to systemically devascularize the uterus with the placenta in site

  • internal iliac artery distal ligation:
  • broad ligament and ureteric dissection:
  • uterine vessels :
  • posterior uterine wall compression suture :
  • The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
  • if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection,
  • anterior uterine wall compression suture :
  • now , we excise the invaded , irreparable anterior wall segment, with the
  • then separation of the placenta manually
  • if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
  • in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
  • refashioning of the Lower segment , repair transversely is usually done,

详细描述

Placental borders and mapping were detected carefully by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively ..

According to the mapping, in a subset of patients we entered the abdomen by transverse suprapubic incision; in another subset we entered the abdomen by infraumbilical midline incision which was extended to a supra umbilical one in cases with anterior placentae with high upper margin .

Followed by bladder peritoneal dissection till either the level of internal Os is reached or a level with extensive adherence and/ or invasion.

Uterus is incised away from the placenta, according to the plan we described by placental mapping.

Type of uterine incisions is determined after placental mapping. Placental borders have been identified, and incisions were made far away from placenta. J-shaped, vertical and upper transverse incisions were used .

研究设计

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

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
  • patient's informed consent about the future risks of conservative management
  • pregnancy > 20 weeks

排除标准

  • * deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
  • cases with total invasion in which the area of invasion is more than 20 min diameter
  • patient refusing conservative management and opting for hysterectomy
  • medical comorbidities making massive hemorrhage more likely such as coagulopathies
  • patient is in active antepartum hemorrhage

结局指标

主要结局

intraoperative blood loss

时间窗: during the operation

Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus

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 M Maged, MD

professor

Cairo University

研究点 (2)

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