Macrosomia, FetalNCT06283277
Fetal Clavicular Measurement to Predict Fetal Macrosomia
An observational study of Macrosomia, Fetal and Large for Gestational Age, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Macrosomia, Fetal, Large for Gestational Age, Shoulder Dystocia
- What is being tested?
- Obstetric Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women with gestational age between 37 weeks and 42 weeks
Who may be able to join
- Singleton pregnancy.
- Gestational age between 37-42 weeks.
- Accepting to be included in the study.
Who cannot join
- Congenital fetal malformation affecting birth weight or affecting clavicle.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fetal Clavicular Measurement to Predict Fetal Macrosomia: A Prospective Cohort Study
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.
Read the 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.
- Being tested
- Obstetric Ultrasound
- Keywords
- macrosomia, Hadlock, clavicle, large for gestational age, LGA, clavicle measurement, Youssef's formula, biacromial diameter, estimated fetal weight., EFW, ultrasound
- Medical subject headings
- Fetal Macrosomia, Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric UltrasoundDevice
Measuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Obstetric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 37-42 weeks of gestation
Secondary outcomes (8)
Establish the relationship between third-trimester clavicle length and shoulder dystocia
establishing if clavicle length is predictive of shoulder dystocia or not.
Measured: Immediately after delivery - postprocedure
Mode of delivery
either vaginal delivery or Cesarean section
Measured: At the day of delivery
Gestational age at the time of delivery.
gestational age and its relation to birth weight
Measured: At the day of delivery
Neonatal Apgar score.
neonatal health evaluation
Measured: postpartum with 1 and 5 minutes
Neonatal bi-acromial diameter
measuring actual neonatal biacromial diameter after delivery and its comparision with ultrasound measured biacromial diameter.
Measured: postpartum within 1 to 5 minutes
Neonatal birth weight
neonatal nurse measuring actual neonatal birth weght in grams using digital scale.
Measured: postpartum within 1 to 5 minutes
Neonatal need for NICU
need for neonatal ICU
Measured: postpartum within 1 minutes to 5 minutes
Neonatal actual clavicle length
measuring actual neonatal clavicle length and its comparison with third trimester ultrasound clavicular measurements.
Measured: postpartum within 1 minutes to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Macrosomia, FetalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mustafa Attyia, Assiut University
- Investigators
- Alaa ElDin Abdelhamid Yusef Hasan, Study director, Emeritus Professor of obstetrics and gynecologyAhmed Mohamed Abbas Sobh, Study director, Assistant Professor of obstetrics and gynecologyMohamed Mahmoud Abdallah Mahmoud, Study director, Lecturer of obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283277
- Sponsor's protocol ID
- fetal macrosomia
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 9731856Boulet 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.
PubMed 12748514Zhang 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.
PubMed 18455528Doty 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.
PubMed 31135729Hadlock 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.
PubMed 6739822Malin 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.
PubMed 26224221Scioscia 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.
PubMed 18165393Zafman 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.
PubMed 30099910Sandmire HF. Whither ultrasonic prediction of fetal macrosomia? Obstet Gynecol. 1993 Nov;82(5):860-2.
PubMed 8414339Aviram 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.
PubMed 28906497Zhang 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.
PubMed 22471679Costantine 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.
PubMed 23147078Youssef 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.
PubMed 29478363Porter 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.
PubMed 25730134
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Clavicular Measurement to Predict Fetal Macrosomia: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06283277
- Acronym / sponsor ID
- fetal macrosomia
- Keywords
- macrosomia, Hadlock, clavicle, large for gestational age, LGA, clavicle measurement, Youssef's formula, biacromial diameter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singleton pregnant women at gestational age between 37-42 weeks | – | Device: Obstetric Ultrasoundestimated fetal weight measured by ultrasound using Hadlock IV formula and Youssef's formula compared with the sensitivity of fetal clavicular measurement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women with gestational age between 37 weeks and 42 weeks
Key inclusion criteria (3 listed)
- Singleton pregnancy.
- Gestational age between 37-42 weeks.
- Accepting to be included in the study.
Key exclusion criteria (1 listed)
- Congenital fetal malformation affecting birth weight or affecting clavicle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric UltrasoundMeasuring fetal clavicular length and estimated fetal weight using Hadlock IV formula and Youssef's formula. | Device | Singleton pregnant women at gestational age between 37-42 weeks |
Primary outcome
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
8 secondary outcomes
Establish the relationship between third-trimester clavicle length and shoulder dystocia
Time frame: Immediately after delivery - postprocedure
Mode of delivery
Time frame: At the day of delivery
Gestational age at the time of delivery.
Time frame: At the day of delivery
Neonatal Apgar score.
Time frame: postpartum with 1 and 5 minutes
Neonatal bi-acromial diameter
Time frame: postpartum within 1 to 5 minutes
Neonatal birth weight
Time frame: postpartum within 1 to 5 minutes
Neonatal need for NICU
Time frame: postpartum within 1 minutes to 5 minutes
Neonatal actual clavicle length
Time frame: postpartum within 1 minutes to 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- BackgroundBarth 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: PubMed 9731856Nesbitt 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.
- Background: PubMed 12748514Boulet 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.
- Background: PubMed 18455528Zhang 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.
- Background: PubMed 31135729Doty 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.
- Background: PubMed 6739822Hadlock 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.
- Background: PubMed 26224221Malin 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.
- Background: PubMed 18165393Scioscia 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.
- Background: PubMed 30099910Zafman 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.
- Background: PubMed 8414339Sandmire HF. Whither ultrasonic prediction of fetal macrosomia? Obstet Gynecol. 1993 Nov;82(5):860-2.
- Background: PubMed 28906497Aviram 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.
- Background: PubMed 22471679Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa ElDin Abdelhamid Yusef Hasan study director
Emeritus Professor of obstetrics and gynecology
Ahmed Mohamed Abbas Sobh study director
Assistant Professor of obstetrics and gynecology
Mohamed Mahmoud Abdallah Mahmoud study director
Lecturer of obstetrics and gynecology
Questions about this trial
What is this clinical trial studying?
An observational study of Macrosomia, Fetal and Large for Gestational Age, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled M Attyia (+201005503250, khaled.hussien@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Third trimester clavicle length measurement (time frame: 37-42 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283277, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.