跳至主要内容
临床试验/NCT04229953
NCT04229953Unknown不适用

Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum: A Prospective Study

Hatem AbuHashim0 个研究点目标入组 113 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
113
主要终点
Diagnostic accuracy of 3D/4D VRU software

研究概览

简要总结

The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome.

Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler. Magnetic resonance imaging (MRI) has been used to predict the depth of placental invasion, but it is expensive and often not immediately available.

Recently, a new imaging technique utilizing three-dimensional (3D)/four-dimensional (4D) volume rendering ultrasound (VRU) was proposed as a promising tool for the preoperative diagnosis of placenta previa accerta spectrum. By using "crystal vue" and "realistic vue" volume rendering mode, it could detect 11 out of 12 cases (91.6%) of PAS which was subsequently confirmed during surgery. Accordingly, The aim of this study is to examine the diagnostic performance of 3D/four-dimensional (4D) volume rendering ultrasound (VRU) for placenta previa accerta spectrum in correlation with the clinical (operative) and pathological findings.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women in their third trimester
  • with a single fetus in the current pregnancy
  • a previous delivery by at least 1 cesarean section
  • having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment

排除标准

  • cases with twin or multiple pregnancies,
  • cases with a non-previa placenta or posterior low lying or previa placenta,
  • cases without previous deliveries by cesarean section
  • cases before the third trimester of pregnancy.

结局指标

主要结局

Diagnostic accuracy of 3D/4D VRU software

时间窗: Intra-operative (i.e. during surgery).

The diagnostic accuracy of 3D/4D VRU software in comparison with the intra operative findings and histopathological confirmation if hysterectomy will be done.

次要结局

未报告次要终点

研究者

发起方
Hatem AbuHashim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatem AbuHashim

Professor

Mansoura University

相似试验