跳至主要内容
临床试验/NCT04314791
NCT04314791已完成不适用

Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum: A Prospective Study

Hatem AbuHashim1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Diagnostic accuracy of the PAI

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.

The placenta accreta index (PAI) score (a nine-point score) was proposed in 2015 to predict PAS based on US parameters in a high-risk population by retrospective data analysis. The probability of histological invasion was found to increase with increasing the PAI score. This study aimed to prospectively evaluate the diagnostic performance of the PAI in the prediction of PAS in relation to histopathological 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 45 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 the PAI

时间窗: through study completion, an average of 1 year

The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.

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

研究点 (1)

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