Fetal Clavicular Measurement to Predict Fetal Macrosomia

Not yet recruiting

• Conditions: Large for Gestational Age; Macrosomia, Fetal; Shoulder Dystocia

• Registration Number: NCT06283277
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-05-01
• Primary Completion: 2027-04-30
• Study Completion: 2027-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Third trimester clavicle length measurement	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

Secondary Outcome Measures

Name	Time	Method
Neonatal bi-acromial diameter	postpartum within 1 to 5 minutes	measuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.
Neonatal Apgar score.	postpartum with 1 and 5 minutes	neonatal health evaluation
Neonatal birth weight	postpartum within 1 to 5 minutes	neonatal nurse measuring actual neonatal birth weght in grams using digital scale.
Neonatal actual clavicle length	postpartum within 1 minutes to 5 minutes	measuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.
Establish the relationship between third-trimester clavicle length and shoulder dystocia	Immediately after delivery - postprocedure	establishing if clavicle length is predictive of shoulder dystocia or not.
Mode of delivery	At the day of delivery	either vaginal delivery or Cesarean section
Gestational age at the time of delivery.	At the day of delivery	gestational age and its relation to birth weight
Neonatal need for NICU	postpartum within 1 minutes to 5 minutes	need for neonatal ICU