NCT07575152

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jul 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2028

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

fetal weight estimationfetal soft tissue thicknessMacrosomiafetal growth restrictionmid-thigh soft tissue thicknessfetal abdominal soft tissue thickness

Outcome Measures

Primary Outcomes (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.

    within 48- 72 hours of delivery

Study Arms (1)

Full term pregnant women

full term pregnant women with in 48-72 hours of delivery either cesarean section, spontaneous vaginal delivery or induced vaginal delivery.

Other: 3rd trimester ultrasound examination within 48-72 hours of delivery

Interventions

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.

Full term pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfull term pregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

full term pregnant women within 48-72 hours before delivery

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 29516387BACKGROUND
  • 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.

    PMID: 15058899BACKGROUND
  • 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.

    PMID: 18307214BACKGROUND
  • 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.

    PMID: 15586365BACKGROUND
  • 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.

    PMID: 15914686BACKGROUND
  • 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.

    PMID: 18226124BACKGROUND
  • 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.

    PMID: 9024084BACKGROUND
  • 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.

    PMID: 11641662BACKGROUND
  • 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.

    PMID: 2027188BACKGROUND
  • 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.

    PMID: 1448248BACKGROUND
  • 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.

    PMID: 15085892BACKGROUND
  • 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.

    PMID: 15505877BACKGROUND
  • 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.

    PMID: 12797002BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Parturition

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Central Study Contacts

Khaled Mustafa Attyia, Master's degree

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

July 30, 2028

Last Updated

May 8, 2026

Record last verified: 2026-05