Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT06456957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020567', 'term': 'Fetal Weight'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity of measuring Fetal Abdominal Subcutaneous Tissue Thickness', 'timeFrame': '37-40 weeks gestation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery.', 'timeFrame': '37-40 weeks gestation', 'description': 'Vaginal delivery or cesarean section'}, {'measure': 'Gestational age at the time of delivery', 'timeFrame': '1 week from recruitment', 'description': 'detection of gestational age at the time of delivery'}, {'measure': 'Neonatal Apgar score', 'timeFrame': 'at the time of delivery', 'description': 'Measure Apgar score for the newborn at 1 minute and 5 minutes'}, {'measure': 'Neonatal birth weight', 'timeFrame': 'at the time of delivery', 'description': 'Measure of Neonatal weight in grams'}, {'measure': 'Neonatal need for NICU', 'timeFrame': 'at the time of delivery', 'description': 'Need for admission of neonate at NICU and Number of days if admitted'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Fetal Weight']}, 'referencesModule': {'references': [{'pmid': '32600245', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31980089', 'type': 'BACKGROUND', '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.'}, {'pmid': '14689530', 'type': 'BACKGROUND', 'citation': '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': '18406510', 'type': 'BACKGROUND', 'citation': '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': '36964980', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHowever, 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.', 'detailedDescription': '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\\].\n\nFetal 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\\].\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women in singleton pregnancy at gestational age between 37 - 40 weeks accepting to be included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton pregnancy.\n2. Gestational age between 37-42 weeks.\n3. Accepting to be included in the study\n\nExclusion Criteria:\n\n1. Pre-gestational diabetes and gestational diabetes.\n2. Other medical disorder as hypertensive disorder during pregnancy, cardiac diseases.\n3. Congenital fetal malformation affecting birth weight or affecting clavicle.'}, 'identificationModule': {'nctId': 'NCT06456957', 'briefTitle': 'Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'FASTT trial'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Mohamed Mahmoud Abdallah', 'investigatorAffiliation': 'Assiut University'}}}}