Clinical trial NCT06283277: Fetal Clavicular Measurement to Predict Fetal Macrosomia
Official title: Fetal Clavicular Measurement to Predict Fetal Macrosomia: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Macrosomia, Fetal
Large for Gestational Age
Shoulder Dystocia
Keywords: macrosomia
Hadlock
clavicle
large for gestational age
LGA
clavicle measurement
Youssef's formula
biacromial diameter
estimated fetal weight.
EFW
ultrasound
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with gestational age between 37 weeks and 42 weeks

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Third trimester clavicle length measurement
timeFrame: 37-42 weeks of gestation
Secondary outcomes:
measure: Establish the relationship between third-trimester clavicle length and shoulder dystocia
timeFrame: Immediately after delivery - postprocedure
measure: Mode of delivery
timeFrame: At the day of delivery
measure: Gestational age at the time of delivery.
timeFrame: At the day of delivery
measure: Neonatal Apgar score.
timeFrame: postpartum with 1 and 5 minutes
measure: Neonatal bi-acromial diameter
timeFrame: postpartum within 1 to 5 minutes
measure: Neonatal birth weight
timeFrame: postpartum within 1 to 5 minutes
measure: Neonatal need for NICU
timeFrame: postpartum within 1 minutes to 5 minutes
measure: Neonatal actual clavicle length
timeFrame: postpartum within 1 minutes to 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Emeritus Professor of obstetrics and gynecology
name: Alaa ElDin Abdelhamid Yusef Hasan
role: STUDY_DIRECTOR
affiliation: Assistant Professor of obstetrics and gynecology
name: Ahmed Mohamed Abbas Sobh
role: STUDY_DIRECTOR
affiliation: Lecturer of obstetrics and gynecology
name: Mohamed Mahmoud Abdallah Mahmoud
role: STUDY_DIRECTOR
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