An observational study in Macrosomia, Fetal, Large for Gestational Age and Shoulder Dystocia, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Assiut University · Observational
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.
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.
pregnant women with gestational age between 37 weeks and 42 weeks
Exclusion Criteria:
estimated fetal weight measured by ultrasound using Hadlock IV formula and Youssef's formula compared with the sensitivity of fetal clavicular measurement.
Device: Obstetric Ultrasound
Measuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula.
Third trimester clavicle length measurement
Sensitivity of third trimester clavicle length measurement in comparison with biacromial diameter and Hadlock IV formula in predicting fetal macrosomia
Time frame: 37-42 weeks of gestation
Establish the relationship between third-trimester clavicle length and shoulder dystocia
establishing if clavicle length is predictive of shoulder dystocia or not.
Time frame: Immediately after delivery - postprocedure
Mode of delivery
either vaginal delivery or Cesarean section
Time frame: At the day of delivery
Gestational age at the time of delivery.
gestational age and its relation to birth weight
Time frame: At the day of delivery
Neonatal Apgar score.
neonatal health evaluation
Time frame: postpartum with 1 and 5 minutes
Neonatal bi-acromial diameter
measuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.
Time frame: postpartum within 1 to 5 minutes
Neonatal birth weight
neonatal nurse measuring actual neonatal birth weght in grams using digital scale.
Time frame: postpartum within 1 to 5 minutes
Neonatal need for NICU
need for neonatal ICU
Time frame: postpartum within 1 minutes to 5 minutes
Neonatal actual clavicle length
measuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.
Time frame: postpartum within 1 minutes to 5 minutes
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Assiut University