跳至主要内容
临床试验/NCT05972915
NCT05972915尚未招募不适用

Separation Sign: New Ultrasound Sign to Rule Out Diagnosis of Placenta Accreta

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
separation sign

研究概览

简要总结

To assess the 'separation sign' as a predictor of normal placental separation in a large cohort of women at risk for placenta accrete spectrum and in a high-risk subgroup with placenta previa or anterior low-lying placenta and have history of at least one previous Cesarean delivery.

详细描述

A prospective Observational Cohort study The study population includes high-risk cohort of women was defined as those who had placenta previa or an anterior low-lying placenta, in addition to at least one previous Cesarean delivery. They will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.

Women will be enrolled in the study after giving written informed consent

The patients will be submitted to:

**Full history taking including: Details of gestational age at the time of scanning, maternal age and risk factors , history of dilatation and curettage, in-vitro fertilization and other previous uterine surgery were assessed.

***Detailed trans-abdominal sonographic examination of the placenta was performed, assessing standard ultrasound markers of PAS. Two experienced sonographic operators performed all examinations using (Toshiba Xario 200) with 3D/4D curved-array trans-abdominal transducer (4-8.5 MHz). All examinations were performed with a full bladder, defined as a volume between 250mL 500mL quantified using the inbuilt ellipsoid volume calculation.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • History of previous cesarean section or hysterotomy.
  • Placenta previa or low lying anterior placenta.
  • From 28 wks to Full term.

排除标准

  • Multiple pregnancies.
  • Medical disorder as diabetes mellitus, hypertension.
  • Obese patients. BMI > 30
  • Intrauterine growth retardation.

结局指标

主要结局

separation sign

时间窗: 1 month before delivery

The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.

次要结局

未报告次要终点

研究者

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

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (1)

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