NCT06283277

Fetal Clavicular Measurement to Predict Fetal Macrosomia

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Macrosomia, Fetal
• Large for Gestational Age
• Shoulder Dystocia

Interventions

Type	Name	Description
DEVICE	Obstetric Ultrasound	Measuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-04-30
• Completion: 2027-10-30
• First posted: 2024-02-28
• Last updated: 2024-02-28