Does Blind Measurement of Biometric Indices Improve the Accuracy of Fetal Weight Estimation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Estimated fetal weight accuracy
研究概览
简要总结
Woman who are expected to give birth in the next 72 hours will be allocated randomly to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. Accuracy of estimations will be compared between the groups.
详细描述
Estimating fetal weight using ultrasound is an essential component in fetal medicine and prenatal treatment.
A study that was conducted as a part of the INTERGROWTH-21 project established international standards for fetal growth by documenting 3 measurements of biometry indices, which included head circumference, abdominal circumference, femur length and biparietal diameter (BPD). The measurements were not disclosed to the investigator in order to prevent bias.
In a recent study it was found that use of the average of the 3 biometric measurements compared with a single measurement for the purposes of estimating fetal weight, is more accurate. However, the measurements were disclosed to the investigator.
Currently, no studies have examined whether there blinded measurements are significantly better than non-blinded measurements.
The aim of this study is to compare blinded to non-blinded biometric measurements for estimation of fetal weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Gestational age between 37 and 41 weeks
- •Expected delivery within 72 hours
排除标准
- •Major Malformations
- •Active labor
研究组 & 干预措施
Blinded
Blinded biometric measurements
干预措施: Blinded estimation of fetal weight (Diagnostic Test)
Non-blinded
Non-blinded biometric measurements
干预措施: Non blinded estimation of fetal weight (Diagnostic Test)
结局指标
主要结局
Estimated fetal weight accuracy
时间窗: From estimation of fetal weight to delivery, up to 72 hours.
Accuracy of fetal weight estimation. A continuous variable, measured as the absolute difference between birthweight and estimated fetal weight in grams.
次要结局
未报告次要终点
研究者
Eran Brazilay, MD PhD
Head of OBGYN ultrasound unit
Assuta Ashdod Hospital