UltrasoundNCT06456957
Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women
An observational study of Ultrasound and Fetal Weight, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ultrasound, Fetal Weight
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women in singleton pregnancy at gestational age between 37 - 40 weeks accepting to be included in the study
Who may be able to join
- Singleton pregnancy.
- Gestational age between 37-42 weeks.
- Accepting to be included in the study
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultrasound, Fetal Weight
- Medical subject headings
- Fetal Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 37-40 weeks gestation
Secondary outcomes (5)
Mode of delivery.
Vaginal delivery or cesarean section
Measured: 37-40 weeks gestation
Gestational age at the time of delivery
detection of gestational age at the time of delivery
Measured: 1 week from recruitment
Neonatal Apgar score
Measure Apgar score for the newborn at 1 minute and 5 minutes
Measured: at the time of delivery
Neonatal birth weight
Measure of Neonatal weight in grams
Measured: at the time of delivery
Neonatal need for NICU
Need for admission of neonate at NICU and Number of days if admitted
Measured: at the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456957
- Sponsor's protocol ID
- FASTT trial
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32600245El-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
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.
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.
PubMed 31980089Bethune 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.
PubMed 14689530Higgins 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.
PubMed 18406510Lindstrom 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.
PubMed 36964980Singh, 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06456957
- Acronym / sponsor ID
- FASTT trial
- Conditions
- Ultrasound, Fetal Weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women in singleton pregnancy at gestational age between 37 - 40 weeks accepting to be included in the study
Key inclusion criteria (3 listed)
- Singleton pregnancy.
- Gestational age between 37-42 weeks.
- Accepting to be included in the study
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Mode of delivery.
Time frame: 37-40 weeks gestation
Gestational age at the time of delivery
Time frame: 1 week from recruitment
Neonatal Apgar score
Time frame: at the time of delivery
Neonatal birth weight
Time frame: at the time of delivery
Neonatal need for NICU
Time frame: at the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 32600245Ebada 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.
- BackgroundEl-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
- BackgroundA 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: PubMed 31980089Lu 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.
- Background: PubMed 14689530Bethune 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.
- Background: PubMed 18406510Higgins 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.
- Background: PubMed 36964980Lindstrom 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.
- BackgroundSingh, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Fetal Weight, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness (time frame: 37-40 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456957, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.