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NCT Number: NCT06283277

Fetal Clavicular Measurement to Predict Fetal Macrosomia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obstetric Ultrasound

Device

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

Primary outcomes

  1. Third trimester clavicle length measurement

    Time frame: 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 outcomes

  1. Establish the relationship between third-trimester clavicle length and shoulder dystocia

    Time frame: Immediately after delivery - postprocedure

    establishing if clavicle length is predictive of shoulder dystocia or not.

  2. Mode of delivery

    Time frame: At the day of delivery

    either vaginal delivery or Cesarean section

  3. Gestational age at the time of delivery.

    Time frame: At the day of delivery

    gestational age and its relation to birth weight

  4. Neonatal Apgar score.

    Time frame: postpartum with 1 and 5 minutes

    neonatal health evaluation

  5. Neonatal bi-acromial diameter

    Time frame: postpartum within 1 to 5 minutes

    measuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.

  6. Neonatal birth weight

    Time frame: postpartum within 1 to 5 minutes

    neonatal nurse measuring actual neonatal birth weght in grams using digital scale.

  7. Neonatal need for NICU

    Time frame: postpartum within 1 minutes to 5 minutes

    need for neonatal ICU

  8. Neonatal actual clavicle length

    Time frame: postpartum within 1 minutes to 5 minutes

    measuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled M Attyia

CONTACT

[email protected]

+201005503250

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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