Fetal Clavicular Measurement to Predict Fetal Macrosomia

NCT06283277 | Not Yet Recruiting

• 1 other identifier: fetal macrosomia
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Immediately after delivery - postprocedure

• Mode of delivery

  At the day of delivery

• Gestational age at the time of delivery.

  At the day of delivery

• Neonatal Apgar score.

  postpartum with 1 and 5 minutes

• Neonatal bi-acromial diameter

  postpartum within 1 to 5 minutes

Study Arms (1)

Singleton pregnant women at gestational age between 37-42 weeks

estimated fetal weight measured by ultrasound using Hadlock IV formula and Youssef's formula compared with the sensitivity of fetal clavicular measurement.

Device: Obstetric Ultrasound

Interventions

Obstetric Ultrasound DEVICE

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

Singleton pregnant women at gestational age between 37-42 weeks

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with gestational age between 37 weeks and 42 weeks

You may qualify if:

• Singleton pregnancy.
• Gestational age between 37-42 weeks.
• Accepting to be included in the study.

You may not qualify if:

• Congenital fetal malformation affecting birth weight or affecting clavicle.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (19)

• 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

  BACKGROUND

• 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.

  PMID: 9731856 BACKGROUND

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  PMID: 31135729 BACKGROUND

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  PMID: 6739822 BACKGROUND

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  PMID: 26224221 BACKGROUND

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  PMID: 18165393 BACKGROUND

• 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.

  PMID: 30099910 BACKGROUND

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  PMID: 8414339 BACKGROUND

• 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.

  PMID: 28906497 BACKGROUND

• 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.

  PMID: 22471679 BACKGROUND

• 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.

  PMID: 23147078 BACKGROUND

• 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.

  PMID: 29478363 BACKGROUND

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  PMID: 25730134 BACKGROUND

• 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.

  PMID: 33843172 BACKGROUND

• 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.

  PMID: 3903198 BACKGROUND

• 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.

  PMID: 16450360 BACKGROUND

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  PMID: 30327863 BACKGROUND

MeSH Terms

Conditions

Fetal Macrosomia; Shoulder Dystocia

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dystocia; Obstetric Labor Complications

Study Officials

• Alaa ElDin Abdelhamid Yusef Hasan

  Emeritus Professor of obstetrics and gynecology

  STUDY DIRECTOR

• Ahmed Mohamed Abbas Sobh

  Assistant Professor of obstetrics and gynecology

  STUDY DIRECTOR

• Mohamed Mahmoud Abdallah Mahmoud

  Lecturer of obstetrics and gynecology

  STUDY DIRECTOR

Central Study Contacts

Khaled M Attyia

CONTACT

+201005503250; khaled.hussien@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 28, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02