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临床试验/NCT04427592
NCT04427592
已完成
不适用

Placenta Accreta; A Vision for Conservative Surgery

Alexandria University1 个研究点 分布在 1 个国家目标入组 159 人2020年7月28日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Placenta Accreta Spectrum
发起方
Alexandria University
入组人数
159
试验地点
1
主要终点
blood transfusion
状态
已完成
最后更新
2年前

概览

简要总结

participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.

Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.

Data were collected about the outcome.

详细描述

Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS. Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels. Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.

注册库
clinicaltrials.gov
开始日期
2020年7月28日
结束日期
2023年5月20日
最后更新
2年前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Mahmoud A Hamdy

principal investigator

Alexandria University

入排标准

入选标准

  • pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.

排除标准

  • pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.
  • pregnant women had 5 or more previous Cesarean sections or their age more than 40 years

结局指标

主要结局

blood transfusion

时间窗: from 48 hours preoperative to 48 hours postoperative.

number of units of blood and it's products transfused to participants

hematuria

时间窗: post-operative up to 24 hours

number of participants suffered hematuria

manual cervical assesment

时间窗: before skin incision

participants were subjected to vaginal examination to asses the cervix lenght

placental separation

时间窗: intra-operative

number of participants whom their placenta was separated manually

wound complications

时间窗: up to 2 weeks postoperative

number of patients suffered wound infection

change in the hemoglobin level

时间窗: from 48 hours pre operative to 48 hours post operative

participant's hemoglobin was measured

high dependency unit admission

时间窗: from 0 to 48 hours postoperative

number of participants needed high dependency unit admission

surgical grading of the placenta

时间窗: intra-operative

number of participants who had accreta, increta, percreta or mixed type

manual assessment of vaginal fornices

时间窗: before skin incision

participants were subjected to vaginal examination to assess fornices

surgical outcome

时间窗: from the time of the surgery until 48 hours after.

number of participants whom their uterus were preserved without major hemorrhage

intra-operative blood loss

时间窗: intraoperative

the amount of blood loss during operation was estimated for each participant.

surgical complications

时间窗: intraoperative

number of participants had bladder, ureter injury or hysterectomy,

internal iliac artery ligation

时间窗: intra-operative

number of participants had with either unilateral or bilateral internal iliac artery ligation

ultrasound grading of the placenta

时间窗: pre-operative

number of participants who were diagnosed by ultrasound as accreta, increta or percreta

repair time

时间窗: intra-operative

the time recorded from the end of the placental separation to the closure of the first layer of the uterus

total operation time

时间窗: intra-operative

the time taken from the start of the skin incision to the skin closure

次要结局

  • defect site(intra-operative)
  • placental bed(intra-operative)
  • pouch site(intra-operative)

研究点 (1)

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