Placenta Accreta; A Vision for Conservative Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- blood transfusion
研究概览
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.
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
- 否
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
研究组 & 干预措施
pregnant women with placenta accreta spectrum
The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.
干预措施: closure of uterine wall defect (Procedure)
pregnant women with placenta accreta spectrum
The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.
干预措施: ultrasound (Diagnostic Test)
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)
研究者
Mahmoud A Hamdy
principal investigator
Alexandria University