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

June 9, 2024 updated by: Mohamed Mahmoud Abdallah, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness
Time Frame: 37-40 weeks gestation
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASTT trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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