Fetal Clavicular Measurement to Predict Fetal Macrosomia

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06283277
Study type	Observational
Source	Assiut University
Contact	Khaled M Attyia
Phone	+201005503250
Email	khaled.hussien@med.aun.edu.eg
Status	Not yet recruiting
Phase
Start date	May 1, 2024
Completion date	October 30, 2027

View Details

See also
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Completed	`NCT03165643` - The DNA Methylation of ARHGEF11 in Macrosomia	N/A
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Recruiting	`NCT05410080` - the Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome
Terminated	`NCT04838431` - A First Trimester Prediction Model for Large for Gestational Age Infants: a Preliminary Study
Withdrawn	`NCT03218735` - Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus	N/A
Recruiting	`NCT06281301` - Improving Patient Understanding of Macrosomia	N/A
Not yet recruiting	`NCT05197101` - To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation	N/A
Recruiting	`NCT06048510` - New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.	N/A
Completed	`NCT05760768` - The Effect of Individualized Exercise Guidance on Pregnancy Outcome	N/A
Not yet recruiting	`NCT05510518` - Late Gestational Diabetes Mellitus Diagnosis in Obese Women
Withdrawn	`NCT02478554` - Antenatal Development Evaluated Prospectively	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.