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NCT Number: NCT06456957

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mode of delivery.

    Time frame: 37-40 weeks gestation

    Vaginal delivery or cesarean section

  2. Gestational age at the time of delivery

    Time frame: 1 week from recruitment

    detection of gestational age at the time of delivery

  3. Neonatal Apgar score

    Time frame: at the time of delivery

    Measure Apgar score for the newborn at 1 minute and 5 minutes

  4. Neonatal birth weight

    Time frame: at the time of delivery

    Measure of Neonatal weight in grams

  5. Neonatal need for NICU

    Time frame: at the time of delivery

    Need for admission of neonate at NICU and Number of days if admitted

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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