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Fetal Clavicular Measurement to Predict Fetal Macrosomia

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06283277
Enrollment
240
Registered
2024-02-28
Start date
2024-05-01
Completion date
2027-10-30
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large for Gestational Age, Macrosomia, Fetal, Shoulder Dystocia

Keywords

macrosomia, Hadlock, clavicle, large for gestational age, LGA, clavicle measurement, Youssef's formula, biacromial diameter, estimated fetal weight., EFW, ultrasound

Brief 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.

Interventions

Measuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Congenital fetal malformation affecting birth weight or affecting clavicle.

Design outcomes

Primary

MeasureTime frameDescription
Third trimester clavicle length measurement37-42 weeks of gestationSensitivity of third trimester clavicle length measurement in comparison with biacromial diameter and Hadlock IV formula in predicting fetal macrosomia

Secondary

MeasureTime frameDescription
Mode of deliveryAt the day of deliveryeither vaginal delivery or Cesarean section
Gestational age at the time of delivery.At the day of deliverygestational age and its relation to birth weight
Neonatal Apgar score.postpartum with 1 and 5 minutesneonatal health evaluation
Establish the relationship between third-trimester clavicle length and shoulder dystociaImmediately after delivery - postprocedureestablishing if clavicle length is predictive of shoulder dystocia or not.
Neonatal birth weightpostpartum within 1 to 5 minutesneonatal nurse measuring actual neonatal birth weght in grams using digital scale.
Neonatal need for NICUpostpartum within 1 minutes to 5 minutesneed for neonatal ICU
Neonatal actual clavicle lengthpostpartum within 1 minutes to 5 minutesmeasuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.
Neonatal bi-acromial diameterpostpartum within 1 to 5 minutesmeasuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.

Contacts

Primary ContactKhaled M Attyia
khaled.hussien@med.aun.edu.eg+201005503250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026