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临床试验/NCT06283277
NCT06283277尚未招募不适用

Fetal Clavicular Measurement to Predict Fetal Macrosomia: A Prospective Cohort Study

Assiut University0 个研究点目标入组 240 人开始时间: 2024年5月1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
240
主要终点
Third trimester clavicle length measurement

研究概览

简要总结

Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.

The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia.

详细描述

Two terms are applied for fetal overgrowth, Large for gestational age (LGA) meaning fetal birth weight (BW) more than 90th percentile for specific gestational age while macrosomia is an absolute value regardless of gestational age which historically defined as 4000-4500 gm. Those two groups have increased risks for neonatal and maternal complications compared to general population and increase sharply when BW >4500gm, the risks of macrosomia are continuum without threshold defining safe and risky outcome, some authors classify macrosomia into 3 grades, grade 1 (4000gm-4499gm), grade 2(4500-4999), grade 3 (≥5000gm).

Despite its implications, the accurate diagnosis is after birth and its prenatal prediction is poor although published formulas for estimating fetal weight shows correlation with BW, however the variability of the estimate is up to 20% with most of formulas, meta-analysis of 29 studies showed sensitivity of 56% and specificity of 92% in predicting BW ≥ 4000gm accuracy of ultrasound decreases with increasing BW, BW>4500 accurate prediction is only 33-44 % of cases. Given the poor predictability of macrosomia, variety of other techniques and formulas are investigated, neither repeated US examination nor growth curves improves predictability, Youssef's formula measuring biacromial diameter (distance by between both acromial processes which joins clavicles at acromioclavicular joints) and macrosomic specific formula seems to be predictive. In study evaluating clavicle length for shoulder dystocia, it found that measuring clavicle was significant for macrosomia however the limitation is small sample size and its comparison with other fetal biometrics may be needed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Singleton pregnancy.
  • Gestational age between 37-42 weeks.
  • Accepting to be included in the study.

排除标准

  • Congenital fetal malformation affecting birth weight or affecting clavicle.

结局指标

主要结局

Third trimester clavicle length measurement

时间窗: 37-42 weeks of gestation

Sensitivity of third trimester clavicle length measurement in comparison with biacromial diameter and Hadlock IV formula in predicting fetal macrosomia

次要结局

  • Neonatal bi-acromial diameter(postpartum within 1 to 5 minutes)
  • Neonatal Apgar score.(postpartum with 1 and 5 minutes)
  • Neonatal birth weight(postpartum within 1 to 5 minutes)
  • Neonatal actual clavicle length(postpartum within 1 minutes to 5 minutes)
  • Establish the relationship between third-trimester clavicle length and shoulder dystocia(Immediately after delivery - postprocedure)
  • Mode of delivery(At the day of delivery)
  • Gestational age at the time of delivery.(At the day of delivery)
  • Neonatal need for NICU(postpartum within 1 minutes to 5 minutes)

研究者

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

Khaled Mustafa Attyia

principal investigator

Assiut University

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