Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women

Ultrasound Clinical Trial

Official title:

Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456957
• Other study ID #: FASTT trial
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: July 2026

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The fetal weight assessment by ultrasound is essential in obstetric practice to determine the labor mode, time, and management. It is an important to detect fetal growth abnormalities such as small for gestational age (SGA), fetal growth restriction (FGR) and large for gestational age (LGA) fetuses; thus, it could help in decreasing the perinatal morbidity and mortality rates [1]. Many methods have been introduced to estimate the weight in utero, and many studies have evaluated their effectiveness to detect the most accurate method [2]. Abnormal fetal growth can be diagnosed by ultrasound. Conventional ultrasonic measurements, such as estimated fetal weight (EFW) and abdominal circumference (AC) can distinguish LGA/macrosomia or LBW infants. Many studies have demonstrated that expected fetal weight (EFW) by the traditional techniques is not a reliable indicator of growth abnormalities; consequently several other sono graphic measurements have been proposed [3]. Ultrasound has its limitations despite the use of more than 50 different formulae to estimate fetal weight as their performance is poor at the extremes of fetal weight. There has been emerging interest in studying fetal soft tissue measurements to improve the detection of growth abnormalities [4].

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 [5].Furthermore, some researchers have investigated links between FASTT and diabetes [6].

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Singleton pregnancy.

2. Gestational age between 37-42 weeks.

3. Accepting to be included in the study

Exclusion Criteria:

1. Pre-gestational diabetes and gestational diabetes.

2. Other medical disorder as hypertensive disorder during pregnancy, cardiac diseases.

3. Congenital fetal malformation affecting birth weight or affecting clavicle.

Related Conditions & MeSH terms

• Body Weight
• Fetal Weight
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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.

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mode of delivery.	Vaginal delivery or cesarean section	37-40 weeks gestation
Secondary	Gestational age at the time of delivery	detection of gestational age at the time of delivery	1 week from recruitment
Secondary	Neonatal Apgar score	Measure Apgar score for the newborn at 1 minute and 5 minutes	at the time of delivery
Secondary	Neonatal birth weight	Measure of Neonatal weight in grams	at the time of delivery
Secondary	Neonatal need for NICU	Need for admission of neonate at NICU and Number of days if admitted	at the time of delivery