Fetal Clavicular Measurement to Predict Fetal Macrosomia

Macrosomia, Fetal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283277
• Other study ID #: fetal macrosomia
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: October 30, 2027

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Khaled M Attyia
• Phone: +201005503250
• Email: khaled.hussien[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystocia
• Fetal Macrosomia
• Macrosomia, Fetal
• Shoulder Dystocia

Intervention

Device:
• Obstetric Ultrasound
Measuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (19)

Aviram A, Yogev Y, Ashwal E, Hiersch L, Danon D, Hadar E, Gabbay-Benziv R. Different formulas, different thresholds and different performance-the prediction of macrosomia by ultrasound. J Perinatol. 2017 Dec;37(12):1285-1291. doi: 10.1038/jp.2017.134. Epub 2017 Sep 14. — View Citation

Barth WH, Jackson R. ACOG PRACTICE BULLETIN Clinical Management Guidelines for Obstetrician-Gynecologists. American collage of obstetricians and gynocologists [Internet]. 2020 Jan;135:18-35. Available from: http://journals.lww.com/greenjournal

Boulet SL, Alexander GR, Salihu HM, Pass M. Macrosomic births in the united states: determinants, outcomes, and proposed grades of risk. Am J Obstet Gynecol. 2003 May;188(5):1372-8. doi: 10.1067/mob.2003.302. — View Citation

Costantine MM, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Maryland. Customized versus population approach for evaluation of fetal overgrowth. Am J Perinatol. 2013 Aug;30(7):565-72. doi: 10.1055/s-0032-1329188. Epub 2012 Nov 12. — View Citation

Doty MS, Chen HY, Sibai BM, Chauhan SP. Maternal and Neonatal Morbidity Associated With Early Term Delivery of Large-for-Gestational-Age But Nonmacrosomic Neonates. Obstet Gynecol. 2019 Jun;133(6):1160-1166. doi: 10.1097/AOG.0000000000003285. — View Citation

Hadlock FP, Deter RL, Harrist RB, Park SK. Estimating fetal age: computer-assisted analysis of multiple fetal growth parameters. Radiology. 1984 Aug;152(2):497-501. doi: 10.1148/radiology.152.2.6739822. — View Citation

Malin GL, Bugg GJ, Takwoingi Y, Thornton JG, Jones NW. Antenatal magnetic resonance imaging versus ultrasound for predicting neonatal macrosomia: a systematic review and meta-analysis. BJOG. 2016 Jan;123(1):77-88. doi: 10.1111/1471-0528.13517. Epub 2015 Jul 29. — View Citation

Nesbitt TS, Gilbert WM, Herrchen B. Shoulder dystocia and associated risk factors with macrosomic infants born in California. Am J Obstet Gynecol. 1998 Aug;179(2):476-80. doi: 10.1016/s0002-9378(98)70382-5. — View Citation

Porter B, Neely C, Szychowski J, Owen J. Ultrasonographic Fetal Weight Estimation: Should Macrosomia-Specific Formulas Be Utilized? Am J Perinatol. 2015 Aug;32(10):968-72. doi: 10.1055/s-0035-1545664. Epub 2015 Mar 2. — View Citation

Sandmire HF. Whither ultrasonic prediction of fetal macrosomia? Obstet Gynecol. 1993 Nov;82(5):860-2. — View Citation

Scioscia M, Vimercati A, Ceci O, Vicino M, Selvaggi LE. Estimation of birth weight by two-dimensional ultrasonography: a critical appraisal of its accuracy. Obstet Gynecol. 2008 Jan;111(1):57-65. doi: 10.1097/01.AOG.0000296656.81143.e6. — View Citation

Sherer DM, Sokolovski M, Dalloul M, Khoury-Collado F, Osho JA, Lamarque MD, Abulafia O. Fetal clavicle length throughout gestation: a nomogram. Ultrasound Obstet Gynecol. 2006 Mar;27(3):306-10. doi: 10.1002/uog.2706. — View Citation

Shmueli A, Salman L, Hadar E, Aviram A, Bardin R, Ashwal E, Gabbay-Benziv R. Sonographic prediction of macrosomia in pregnancies complicated by maternal diabetes: finding the best formula. Arch Gynecol Obstet. 2019 Jan;299(1):97-103. doi: 10.1007/s00404-018-4934-y. Epub 2018 Oct 16. — View Citation

Terzi E. A new approach to predicting shoulder dystocia: fetal clavicle measurement. Turk J Med Sci. 2021 Aug 30;51(4):1932-1939. doi: 10.3906/sag-2011-145. — View Citation

Yarkoni S, Schmidt W, Jeanty P, Reece EA, Hobbins JC. Clavicular measurement: a new biometric parameter for fetal evaluation. J Ultrasound Med. 1985 Sep;4(9):467-70. doi: 10.7863/jum.1985.4.9.467. — View Citation

Youssef AEA, Amin AF, Khalaf M, Khalaf MS, Ali MK, Abbas AM. Fetal biacromial diameter as a new ultrasound measure for prediction of macrosomia in term pregnancy: a prospective observational study. J Matern Fetal Neonatal Med. 2019 Aug;32(16):2674-2679. doi: 10.1080/14767058.2018.1445714. Epub 2018 Mar 7. — View Citation

Zafman KB, Bergh E, Fox NS. Accuracy of sonographic estimated fetal weight in suspected macrosomia: the likelihood of overestimating and underestimating the true birthweight. J Matern Fetal Neonatal Med. 2020 Mar;33(6):967-972. doi: 10.1080/14767058.2018.1511697. Epub 2018 Sep 3. — View Citation

Zhang J, Kim S, Grewal J, Albert PS. Predicting large fetuses at birth: do multiple ultrasound examinations and longitudinal statistical modelling improve prediction? Paediatr Perinat Epidemiol. 2012 May;26(3):199-207. doi: 10.1111/j.1365-3016.2012.01261.x. Epub 2012 Feb 10. — View Citation

Zhang X, Decker A, Platt RW, Kramer MS. How big is too big? The perinatal consequences of fetal macrosomia. Am J Obstet Gynecol. 2008 May;198(5):517.e1-6. doi: 10.1016/j.ajog.2007.12.005. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Third trimester clavicle length measurement	Sensitivity of third trimester clavicle length measurement in comparison with biacromial diameter and Hadlock IV formula in predicting fetal macrosomia	37-42 weeks of gestation
Secondary	Establish the relationship between third-trimester clavicle length and shoulder dystocia	establishing if clavicle length is predictive of shoulder dystocia or not.	Immediately after delivery - postprocedure
Secondary	Mode of delivery	either vaginal delivery or Cesarean section	At the day of delivery
Secondary	Gestational age at the time of delivery.	gestational age and its relation to birth weight	At the day of delivery
Secondary	Neonatal Apgar score.	neonatal health evaluation	postpartum with 1 and 5 minutes
Secondary	Neonatal bi-acromial diameter	measuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.	postpartum within 1 to 5 minutes
Secondary	Neonatal birth weight	neonatal nurse measuring actual neonatal birth weght in grams using digital scale.	postpartum within 1 to 5 minutes
Secondary	Neonatal need for NICU	need for neonatal ICU	postpartum within 1 minutes to 5 minutes
Secondary	Neonatal actual clavicle length	measuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.	postpartum within 1 minutes to 5 minutes