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Fetal MacrosomiaNCT07575152

Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness

An observational study of Fetal Macrosomia and Intrauterine Growth Disorders (IUGR and Macrosomia), run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Traditional methods for estimating fetal weight (EFW) often miss the mark because they focus on bone and circumference while ignoring fetal fat. This study proposes a more inclusive formula to fix that. Current models (using BPD, HC, AC, and FL) are the standard but suffer from high observer variability. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
3rd trimester ultrasound examination within 48-72 hours of delivery
Type of treatment
Injection or infusion
How many people
300 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 30 Jul 2028
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: full term pregnant women within 48-72 hours before delivery

Who may be able to join

  • Singleton Gestation.
  • Gestational Age: Participants must be at a term ≥ 37 weeks
  • Timing of Examination: Sonographic EFW must be performed within 48 -72 hours prior to delivery.
  • Welling to share in the study.

Who cannot join

  • Fetal Anomalies.
  • Amniotic Fluid Disorders: oligohydramnios or polyhydramnios
  • Maternal morbid obesity (BMI > 40 kg/m2)
  • Maternal medical disorders: as diabetes, hypertension, systemic lupus erythromatosis or others affecting fetal growth
  • Fetal Hydrops
  • Fetal Malpresentation
  • Fetal growth restriction

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Khaled Mustafa Attyia, Master's degree contact

+201005503250

khaled.hussien@med.aun.edu.eg

About this study

Official title: Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness: Cross Sectional Study.

Traditional methods for estimating fetal weight (EFW) often miss the mark because they focus on bone and circumference while ignoring fetal fat. This study proposes a more inclusive formula to fix that. Current models (using BPD, HC, AC, and FL) are the standard but suffer from high observer variability. These formulas struggle at the extremes (macrosomia or growth restriction) and fail to account for fetal adiposity, which makes up 10-12% of a newborn's mass. The study introduces a novel formula that moves beyond simple bone measurements by integrating Soft Tissue Thickness (STT). By accounting for a broader range of biological variants and fat distribution, this new model aims to provide a non-inferior, more precise predictive value for fetal weight compared to traditional methods.

Read the detailed description

Accurate estimation of fetal weight (EFW) is fundamental to modern obstetric management. Traditional sonographic biometry-utilizing biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), and femur length (FL)-is the standard for predictive modeling. However, these parameters are limited by significant inter- and intra-observer variability and a loss of precision at the extremes of fetal weight, such as in cases of macrosomia or growth restriction. Furthermore, conventional formulas often fail to account for fetal adiposity, which constitutes 10-12% of total neonatal body mass. Recent literature suggests that the integration of soft tissue thickness (STT) measurements-specifically mid-arm, subscapular, abdominal subcutaneous, and mid-thigh thickness-can enhance the accuracy of EFW. While the Scioscia and modified Scioscia formulas rely exclusively on FL and mid-thigh measurements, this study proposes a novel, multi-parametric approach. By combining AC, fetal abdominal subcutaneous tissue thickness, FL, and mid-thigh soft tissue thickness, we hypothesize that our formula offers a non-inferior predictive value. This model accounts for a broader range of biological variants and soft tissue distribution patterns that significantly influence overall fetal mass.

Detailed history (maternal age, obstetric history, medical history, previous macrosomic fetuses, previous shoulder dystocia). Gestational age is calculated from the first day of the last menstrual period and confirmed by either a first- or second-trimester ultrasound scan. When the ultrasound-determined gestational age differed from that calculated from the last menstrual period by >7 days in the first trimester, or by >10 days in the second trimester, the ultrasound-determined gestational age is used.

The study will be bi-phasic, 1st phase is model development phase in which we develop a mathematical model for fetal weight estimation incorporating (abdominal circumference, fetal abdominal subcutaneous soft tissue thickness, femur length, mid-thigh soft tissue thickness), the 2nd phase is a validation and comparison phase in which we test our model and compare it to modified Scioscia formula and conventional Hadlock formula.

For measurement of femur length (FL) Each caliper is placed at the ends of the ossified diaphysis without including the distal femoral epiphysis if it is visible.

For the measurement of AC, the transverse section of the fetal abdomen should be as circular as possible, and the fetal spine preferably in the 3- or 9-o'clock position, umbilical vein at the level of the portal sinus, stomach visible and kidneys not visible. The AC is measured directly at the outer surface of the skin line, with ellipse calipers.

Mid-thigh STT: measured linearly in the standard longitudinal section used for FL measurement. In the middle third of the fetal thigh, with the femur lying parallel to the transducer, mid-thigh STT was measured from the outer margin of the skin to the outer margin of the femur shaft. The measurement was taken, providing that the greater and the lesser trochanter are turned upwards. This section assures the correct view of the lateral side of the femur (vastus lateralis, which is the biggest part of the quadriceps femoris) Abdominal Subcutaneous STT: Measured at the level of the AC plane, anterior 1/3rd of abdominal circumference between outer and inner edges of abdominal wall by ultrasound.

Actual birth weight (AFW) was immediately measured after delivery by a neonatologist using digital medical neonatal scale.

Being tested
3rd trimester ultrasound examination within 48-72 hours of delivery
Keywords
fetal weight estimation, fetal soft tissue thickness, Macrosomia, fetal growth restriction, mid-thigh soft tissue thickness, fetal abdominal soft tissue thickness
Medical subject headings
Fetal Macrosomia, Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3rd trimester ultrasound examination within 48-72 hours of deliveryOther

    ultrasound examination of full-term pregnant women with 48-72 hours of delivery measuring Abdominal circumference, fetal abdominal subcutaneous soft tissue thickness, femur length and mid-thigh soft tissue thickness.

Study groups in NCT07575152
Study groupRoleWhat they receive
Full term pregnant womenfull term pregnant women with in 48-72 hours of delivery either cesarean section, spontaneous vaginal delivery or induced vaginal delivery.
Receives: Other: 3rd trimester ultrasound examination within 48-72 hours of delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. development and validation of novel method for fetal weight estimation

    a novel module for fetal weight estimation depending on abdominal circumference, fetal abdominal subcutaneous soft tissue thickness, femur length, mid-thigh soft tissue thickness.

    Measured: within 48- 72 hours of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Jul 2028 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575152
Sponsor's protocol ID
AssiutFetalWT
Status last verified
May 2026
First submitted
4 May 2026
Last updated
12 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Paydary K, Seraj SM, Zadeh MZ, Emamzadehfard S, Shamchi SP, Gholami S, Werner TJ, Alavi A. The Evolving Role of FDG-PET/CT in the Diagnosis, Staging, and Treatment of Breast Cancer. Mol Imaging Biol. 2019 Feb;21(1):1-10. doi: 10.1007/s11307-018-1181-3.

    PubMed 29516387
  • Deter RL. Individualized growth assessment: evaluation of growth using each fetus as its own control. Semin Perinatol. 2004 Feb;28(1):23-32. doi: 10.1053/j.semperi.2003.10.011.

    PubMed 15058899
  • Scioscia M, Scioscia F, Vimercati A, Caradonna F, Nardelli C, Pinto LR, Selvaggi LE. Estimation of fetal weight by measurement of fetal thigh soft-tissue thickness in the late third trimester. Ultrasound Obstet Gynecol. 2008 Mar;31(3):314-20. doi: 10.1002/uog.5253.

    PubMed 18307214
  • Lee W, Deter RL, McNie B, Goncalves LF, Espinoza J, Chaiworapongsa T, Romero R. Individualized growth assessment of fetal soft tissue using fractional thigh volume. Ultrasound Obstet Gynecol. 2004 Dec;24(7):766-74. doi: 10.1002/uog.1779.

    PubMed 15586365
  • Lee W, Deter RL, McNie B, Goncalves LF, Espinoza J, Chaiworapongsa T, Balasubramaniam M, Romero R. The fetal arm: individualized growth assessment in normal pregnancies. J Ultrasound Med. 2005 Jun;24(6):817-28.

    PubMed 15914686
  • Larciprete G, Di Pierro G, Barbati G, Deaibess T, Jarvis S, Valensise H, Romanini ME, Gioia S, Arduini D. Could birthweight prediction models be improved by adding fetal subcutaneous tissue thickness? J Obstet Gynaecol Res. 2008 Feb;34(1):18-26. doi: 10.1111/j.1447-0756.2007.00741.x.

    PubMed 18226124
  • Bernstein IM, Goran MI, Amini SB, Catalano PM. Differential growth of fetal tissues during the second half of pregnancy. Am J Obstet Gynecol. 1997 Jan;176(1 Pt 1):28-32. doi: 10.1016/s0002-9378(97)80006-3.

    PubMed 9024084
  • Galan HL, Rigano S, Radaelli T, Cetin I, Bozzo M, Chyu J, Hobbins JC, Ferrazzi E. Reduction of subcutaneous mass, but not lean mass, in normal fetuses in Denver, Colorado. Am J Obstet Gynecol. 2001 Oct;185(4):839-44. doi: 10.1067/mob.2001.117350.

    PubMed 11641662
  • Skovron ML, Berkowitz GS, Lapinski RH, Kim JM, Chitkara U. Evaluation of early third-trimester ultrasound screening for intrauterine growth retardation. J Ultrasound Med. 1991 Mar;10(3):153-9. doi: 10.7863/jum.1991.10.3.153.

    PubMed 2027188
  • Chang TC, Robson SC, Boys RJ, Spencer JA. Prediction of the small for gestational age infant: which ultrasonic measurement is best? Obstet Gynecol. 1992 Dec;80(6):1030-8.

    PubMed 1448248
  • Kurmanavicius J, Burkhardt T, Wisser J, Huch R. Ultrasonographic fetal weight estimation: accuracy of formulas and accuracy of examiners by birth weight from 500 to 5000 g. J Perinat Med. 2004;32(2):155-61. doi: 10.1515/JPM.2004.028.

    PubMed 15085892
  • Dudley NJ. A systematic review of the ultrasound estimation of fetal weight. Ultrasound Obstet Gynecol. 2005 Jan;25(1):80-9. doi: 10.1002/uog.1751.

    PubMed 15505877
  • Rosati P, Exacoustos C, Caruso A, Mancuso S. Ultrasound diagnosis of fetal macrosomia. Ultrasound Obstet Gynecol. 1992 Jan 1;2(1):23-9. doi: 10.1046/j.1469-0705.1992.02010023.x.

    PubMed 12797002

Questions about this trial

What is this clinical trial studying?

An observational study of Fetal Macrosomia and Intrauterine Growth Disorders (IUGR and Macrosomia), 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 4 inclusion and 7 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 12 May 2026. 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 Mustafa Attyia, Master's degree (+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?

development and validation of novel method for fetal weight estimation (time frame: within 48- 72 hours of delivery). 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 NCT07575152, which also lists 13 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 12 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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