NCT06456957

Brief Summary

Fetal Abdominal subcutaneous tissue thickness (FASTT) can be easily measured during the routine ultrasound examination of pregnant women. Numerous reports have shown FASTT measurement to be a good way of evaluating subcutaneous fat tissue. However, to the best of our knowledge, no studies have investigated the association of FASTT with abnormal fetal growth in nondiabetic. For this reason, in this study we evaluated whether FASTT can predict birth weight or diagnose LGA and/or LBW infants in the third trimester.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2024

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

Study Progress92%
Sep 2024Jul 2026

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 9, 2024

Last Update Submit

June 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness

    To evaluate sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness compared to Hadlock formula IV in Prediction of Fetal Weight in Term non-diabetic Pregnant Women in 3rd trimester.

    37-40 weeks gestation

Secondary Outcomes (5)

  • Mode of delivery.

    37-40 weeks gestation

  • Gestational age at the time of delivery

    1 week from recruitment

  • Neonatal Apgar score

    at the time of delivery

  • Neonatal birth weight

    at the time of delivery

  • Neonatal need for NICU

    at the time of delivery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women in singleton pregnancy at gestational age between 37 - 40 weeks accepting to be included in the study

You may qualify if:

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

You may not qualify if:

  • Pre-gestational diabetes and gestational diabetes.
  • Other medical disorder as hypertensive disorder during pregnancy, cardiac diseases.
  • Congenital fetal malformation affecting birth weight or affecting clavicle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Ebada MA, Elmatboly AM, Baligh G. Intravenous Oxytocin versus Intramuscular Oxytocin for the Management of Postpartum Hemorrhage: A Systematic Review and Meta-Analysis. Curr Drug Res Rev. 2020;12(2):150-157. doi: 10.2174/2589977512666200628013647.

    PMID: 32600245BACKGROUND
  • El-Sayed MR, Soliman BS, Zaitoun MM, Shorbaji E, Mohammed RJ. Clinical and ultrasound estimation of fetal weight at term and its accuracy with birth weight. The Egyptian Journal of Hospital Medicine. 2020 Oct 1;81(7):2468-75

    BACKGROUND
  • A Oun Y, M Gebril M, M El-Mazzaly S. Measurement of Fetal Abdominal Subcutaneous Tissue Thickness by Ultrasound in Prediction of Birth Weight at Term Pregnancy. Al-Azhar Medical Journal. 2020 Oct 1;49(4):1653-62.

    BACKGROUND
  • Lu Y, Fu X, Chen F, Wong KKL. Prediction of fetal weight at varying gestational age in the absence of ultrasound examination using ensemble learning. Artif Intell Med. 2020 Jan;102:101748. doi: 10.1016/j.artmed.2019.101748. Epub 2019 Nov 17.

    PMID: 31980089BACKGROUND
  • Bethune M, Bell R. Evaluation of the measurement of the fetal fat layer, interventricular septum and abdominal circumference percentile in the prediction of macrosomia in pregnancies affected by gestational diabetes. Ultrasound Obstet Gynecol. 2003 Dec;22(6):586-90. doi: 10.1002/uog.885.

    PMID: 14689530BACKGROUND
  • Higgins MF, Russell NM, Mulcahy CH, Coffey M, Foley ME, McAuliffe FM. Fetal anterior abdominal wall thickness in diabetic pregnancy. Eur J Obstet Gynecol Reprod Biol. 2008 Sep;140(1):43-7. doi: 10.1016/j.ejogrb.2008.02.021. Epub 2008 Apr 11.

    PMID: 18406510BACKGROUND
  • Lindstrom L, Cnattingius S, Axelsson O, Granfors M. Accuracy and precision of sonographic fetal weight estimation in Sweden. Acta Obstet Gynecol Scand. 2023 Jun;102(6):699-707. doi: 10.1111/aogs.14554. Epub 2023 Mar 25.

    PMID: 36964980BACKGROUND
  • Singh, A., Chander, R. and Kumari, S. (2014) Estimation of Fetal Weight and Its Correlation with Actual Birth Weight by Sonographic Measurement of Fetal Abdominal Subcutaneous Tissue Thickness. Journal of Evolution of Medical and Dental Sciences , 3, 9610-9621. https://doi.org/10.14260/jemds/2014/3244

    BACKGROUND

MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

June 13, 2024

Record last verified: 2024-06