跳至主要内容
临床试验/NCT04801706
NCT04801706Unknown不适用

Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum: A Prospective Cohort Study

Assiut University0 个研究点目标入组 158 人开始时间: 2021年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
158
主要终点
To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens

研究概览

简要总结

To evaluate the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens

详细描述

Evaluation of the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens The following ultrasound items will be examined: number and viability of fetuses, amniotic fluid assessment, fetal biometries, fetal gender if possible, fetal presentation, Estimated fetal weight using Hadlock formula, Umbilical Artery Pulsatility Index (UA PI) measured from an automated/manual trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The UA PI will be recorded from a free-floating section of cord.

Next step the investigators will look for suggestive ultrasound parameters of placenta accreta including:

  1. Location of placenta: Placenta previa anterior / posterior / totally covering the internal cervical os.
  2. Lacunae staging according to Finberg and Williams as follows: grade 0, none seen; grade 1, 1-3 present and generally small; grade 2, 4-6 present and tending to be larger and more irregular; grade 3, many throughout the placenta and appearing large and bizarre.
  3. Loss of the clear zone, defined as loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed
  4. Bladder wall interruption, defined as loss or interruption of the bright bladder wall (hyperechoic band or 'line' between the uterine serosa and bladder lumen)
  5. Uterovescical hypervascularity, defined as a striking amount of color Doppler signal seen between the myometrium and the posterior wall of the bladder, including vessels appearing to extend from the placenta, across the myometrium and beyond the serosa, into the bladder or other organs, often running perpendicular to the myometrium.
  6. Increased vascularity in the parametrial region, defined as the presence of hypervascularity extending beyond the lateral uterine walls and involving the region of the parametria .

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients diagnosed with placenta previa previa or low lying placenta during pregnancy at any gestational age will be included and followed up until termination of pregnancy. The diagnosis of placenta previa was based on the presence of placental tissue overing the internal cervical os and Low-lying placenta was diagnosed when the placenta was within 2 cm from the internal cervical os but did not cover it

排除标准

  • Impaired liver or renal functions.
  • Coagulation disorders.
  • Associated uterine pathology needing hysterectomy.
  • Patient's refusal to participate in clinical research.
  • Multiple pregnancy

结局指标

主要结局

To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens

时间窗: Bseline

Grade 1 : Complete placental separation at third stage, Grade 2 : removal of placenta required and parts of placenta thought to be abnormally adherent, Grade 3 : Manual removal of placenta required and the whole placental bed thought to be abnormally adherent, Grade 4 : Placental tissue seen to have invaded through the serosa of the uterus but a clear surgical plane can be identified between the bladder and uterus, Grade 5 : Placental tissue seen to have invaded through the serosa of the uterus and a clear surgical plane cannot be identified between the bladder and uterus, Grade 6 : Placental tissue seen to have invaded through the serosa of the uterus and infiltrating the parametrium or any organ other than the urinary bladder

次要结局

  • Association of each ultrasonographic parameter of placental invasion with maternal and fetal complications(Baseline)

研究者

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

Ahmad Sayed Reyad

Assiut University, Women Health Hospital

Assiut University

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