跳至主要内容
临床试验/NCT02443597
NCT02443597已完成不适用

Can Increased Body Mass Index Prevent Adequate Ultrasound Examination for Trisomy 21 Risk Assessment?

Benha University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.

研究概览

简要总结

Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for aneuploidy risk assessment.

详细描述

Obesity is a common public health problem which is increasing worldwide at an alarming rate. According to National nutrition survey statistics of 2007, the prevalence of obesity in the kingdom of Saudi Arabia was 23.6% in women and 14% in men. Also the prevalence of overweight in the Saudi community was determined to be 30.7% for men as compared to 28.4% for the women.

First trimester screening between 11-14 weeks gestation is known to be an effective and reliable screening test for Down syndrome and trisomy 18.First trimester screening allows earlier identification of the pregnancy at risk for fetal aneuploidy and anatomic defects, particularly, cardiac anomalies, therefore, providing an option of earlier diagnosis by chorionic villus sampling and analysis of amniocytes.

The well-known association of obesity during pregnancy with a variety of maternal and fetal complications increases the importance of early aneuploidy screening.

Fetal aneuploidy risk assessment is based on a combination of maternal age, prior affected pregnancy or family history, maternal serum biochemical tests and fetal ultrasound markers.

The impact of obesity on the quality of prenatal ultrasound examination is well established with a greater risk for suboptimal visualization, in particular, the fetal cardiac structures and the craniospinal structures only when body mass index above the 90th percentile.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation.

排除标准

  • multiple gestation.
  • fetal size outside of nuchal translucency screening age (crown-rump length (CRL) outside of 46-71 mm).
  • presence of a cystic hygroma.
  • fetal demise.

结局指标

主要结局

Cutoff body mass index for the use of transvaginal ultrasound for aneuploidy risk assessment.

时间窗: 30 minutes

次要结局

  • The time of the study. (time needed for satisfactory ultrasound risk assessment in minutes)(30 minutes)
  • The tolerance of the woman for trans-vaginal ultrasound.(30 minutes)
  • The harmful effect to the patient(12 hours)

研究者

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

ahmed abdulmoneim altraigey

lecturer

Benha University

研究点 (1)

Loading locations...

相似试验