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临床试验/NCT06100640
NCT06100640已完成不适用

Paracervical Pouch Significance in Placenta Accreta Spectrum

Alexandria University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2023年12月30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
190
试验地点
1
主要终点
blood transfusion

研究概览

简要总结

The study objective is the significance of the ultrasound detection of the paracervical pouch in placenta accreta spectrum. It aimed to evaluate its relation to the degree of placenta accreta spectrum, amount of the blood loss and the number of packed red blood cells transfused.

详细描述

The study will be carried on patients diagnosed with placenta previa or placenta accreta spectrum and had at least one caesarean section. The study will be divided into 2 groups of 70 patients at least per each. The first group will include patients in whom a paracervical pouch is detected, and the second group will include patients in whom the pouch is not detected by transvaginal ultrasound.

paracervical pouch is defined ultrasonographic as the downward displacement of the uterine serosa from the level of the cervical internal os

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • • Patients between 19 to 40 years old
  • Patients had at least one cesarean section.

排除标准

  • • Patients who request hysterectomy.
  • Patients diagnosed with hepatitis B, C, or HIV,
  • Those with bleeding diathesis.
  • Patients whose BMI is more than 40 kg/m
  • Patients who need an emergency cesarean section.

结局指标

主要结局

blood transfusion

时间窗: intraoperative and 24 hours postoperative

the amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups.

internal iliac artery ligation

时间窗: intraoperative

the rate of internal iliac artery ligation in both groups.

Intensive care unit admission

时间窗: postoperative for 5 days

the number of patients admitted to the intensive care unit and the duration of their stay.

hospital stays

时间窗: postoperative for 1 month

the duration of hospital stays after the operation.

the rate of intraoperative diagnosis of placenta accreta spectrum

时间窗: intraoperative

the number of patients diagnosed intraoperatively with placenta accreta spectrum according to international federation of obstetrics and gynecology in both groups.

calculated amount of blood loss

时间窗: intraoperative and 24 hours postoperative

the total amount blood lost intraoperatively in millilitres.

the presence of intraoperative pouch

时间窗: intraoperative

the detection of an intraoperative paracervical pouch grossly.

rate of hysterectomy

时间窗: intraoperative till 40 days postoperative

the percentage of cases had hysterectomy in both groups.

次要结局

  • total operation time(intraoperative)
  • preoperative hemoglobin levels in gm/dl(24 hours before the operation)
  • rate of uterine wall disruption(intraoperative)
  • postoperative hemoglobin levels in gm/dl(6 hours postoperative)
  • repair time(intraoperative)

研究者

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

Omar elshorbagy

lecturer in obstetrics and gynecology, faculty of medicine

Alexandria University

研究点 (1)

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