- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07575152
Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness
Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness: Cross Sectional Study.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Accurate estimation of fetal weight (EFW) is fundamental to modern obstetric management. Traditional sonographic biometry-utilizing biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), and femur length (FL)-is the standard for predictive modeling. However, these parameters are limited by significant inter- and intra-observer variability and a loss of precision at the extremes of fetal weight, such as in cases of macrosomia or growth restriction. Furthermore, conventional formulas often fail to account for fetal adiposity, which constitutes 10-12% of total neonatal body mass. Recent literature suggests that the integration of soft tissue thickness (STT) measurements-specifically mid-arm, subscapular, abdominal subcutaneous, and mid-thigh thickness-can enhance the accuracy of EFW. While the Scioscia and modified Scioscia formulas rely exclusively on FL and mid-thigh measurements, this study proposes a novel, multi-parametric approach. By combining AC, fetal abdominal subcutaneous tissue thickness, FL, and mid-thigh soft tissue thickness, we hypothesize that our formula offers a non-inferior predictive value. This model accounts for a broader range of biological variants and soft tissue distribution patterns that significantly influence overall fetal mass.
Detailed history (maternal age, obstetric history, medical history, previous macrosomic fetuses, previous shoulder dystocia). Gestational age is calculated from the first day of the last menstrual period and confirmed by either a first- or second-trimester ultrasound scan. When the ultrasound-determined gestational age differed from that calculated from the last menstrual period by >7 days in the first trimester, or by >10 days in the second trimester, the ultrasound-determined gestational age is used.
The study will be bi-phasic, 1st phase is model development phase in which we develop a mathematical model for fetal weight estimation incorporating (abdominal circumference, fetal abdominal subcutaneous soft tissue thickness, femur length, mid-thigh soft tissue thickness), the 2nd phase is a validation and comparison phase in which we test our model and compare it to modified Scioscia formula and conventional Hadlock formula.
For measurement of femur length (FL) Each caliper is placed at the ends of the ossified diaphysis without including the distal femoral epiphysis if it is visible.
For the measurement of AC, the transverse section of the fetal abdomen should be as circular as possible, and the fetal spine preferably in the 3- or 9-o'clock position, umbilical vein at the level of the portal sinus, stomach visible and kidneys not visible. The AC is measured directly at the outer surface of the skin line, with ellipse calipers.
Mid-thigh STT: measured linearly in the standard longitudinal section used for FL measurement. In the middle third of the fetal thigh, with the femur lying parallel to the transducer, mid-thigh STT was measured from the outer margin of the skin to the outer margin of the femur shaft. The measurement was taken, providing that the greater and the lesser trochanter are turned upwards. This section assures the correct view of the lateral side of the femur (vastus lateralis, which is the biggest part of the quadriceps femoris) Abdominal Subcutaneous STT: Measured at the level of the AC plane, anterior 1/3rd of abdominal circumference between outer and inner edges of abdominal wall by ultrasound.
Actual birth weight (AFW) was immediately measured after delivery by a neonatologist using digital medical neonatal scale.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Khaled Mustafa Attyia, Master's degree
- Numéro de téléphone: +201005503250
- E-mail: khaled.hussien@med.aun.edu.eg
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Singleton Gestation.
- Gestational Age: Participants must be at a term ≥ 37 weeks
- Timing of Examination: Sonographic EFW must be performed within 48 -72 hours prior to delivery.
- Welling to share in the study.
Exclusion Criteria:
- Fetal Anomalies.
- Amniotic Fluid Disorders: oligohydramnios or polyhydramnios
- Maternal morbid obesity (BMI > 40 kg/m2)
- Maternal medical disorders: as diabetes, hypertension, systemic lupus erythromatosis or others affecting fetal growth
- Fetal Hydrops
- Fetal Malpresentation
- Fetal growth restriction
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Full term pregnant women
full term pregnant women with in 48-72 hours of delivery either cesarean section, spontaneous vaginal delivery or induced vaginal delivery.
|
ultrasound examination of full-term pregnant women with 48-72 hours of delivery measuring Abdominal circumference, fetal abdominal subcutaneous soft tissue thickness, femur length and mid-thigh soft tissue thickness.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
development and validation of novel method for fetal weight estimation
Délai: within 48- 72 hours of delivery
|
a novel module for fetal weight estimation depending on abdominal circumference, fetal abdominal subcutaneous soft tissue thickness, femur length, mid-thigh soft tissue thickness.
|
within 48- 72 hours of delivery
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Paydary K, Seraj SM, Zadeh MZ, Emamzadehfard S, Shamchi SP, Gholami S, Werner TJ, Alavi A. The Evolving Role of FDG-PET/CT in the Diagnosis, Staging, and Treatment of Breast Cancer. Mol Imaging Biol. 2019 Feb;21(1):1-10. doi: 10.1007/s11307-018-1181-3.
- Deter RL. Individualized growth assessment: evaluation of growth using each fetus as its own control. Semin Perinatol. 2004 Feb;28(1):23-32. doi: 10.1053/j.semperi.2003.10.011.
- Scioscia M, Scioscia F, Vimercati A, Caradonna F, Nardelli C, Pinto LR, Selvaggi LE. Estimation of fetal weight by measurement of fetal thigh soft-tissue thickness in the late third trimester. Ultrasound Obstet Gynecol. 2008 Mar;31(3):314-20. doi: 10.1002/uog.5253.
- Lee W, Deter RL, McNie B, Goncalves LF, Espinoza J, Chaiworapongsa T, Romero R. Individualized growth assessment of fetal soft tissue using fractional thigh volume. Ultrasound Obstet Gynecol. 2004 Dec;24(7):766-74. doi: 10.1002/uog.1779.
- Lee W, Deter RL, McNie B, Goncalves LF, Espinoza J, Chaiworapongsa T, Balasubramaniam M, Romero R. The fetal arm: individualized growth assessment in normal pregnancies. J Ultrasound Med. 2005 Jun;24(6):817-28.
- Larciprete G, Di Pierro G, Barbati G, Deaibess T, Jarvis S, Valensise H, Romanini ME, Gioia S, Arduini D. Could birthweight prediction models be improved by adding fetal subcutaneous tissue thickness? J Obstet Gynaecol Res. 2008 Feb;34(1):18-26. doi: 10.1111/j.1447-0756.2007.00741.x.
- Bernstein IM, Goran MI, Amini SB, Catalano PM. Differential growth of fetal tissues during the second half of pregnancy. Am J Obstet Gynecol. 1997 Jan;176(1 Pt 1):28-32. doi: 10.1016/s0002-9378(97)80006-3.
- Galan HL, Rigano S, Radaelli T, Cetin I, Bozzo M, Chyu J, Hobbins JC, Ferrazzi E. Reduction of subcutaneous mass, but not lean mass, in normal fetuses in Denver, Colorado. Am J Obstet Gynecol. 2001 Oct;185(4):839-44. doi: 10.1067/mob.2001.117350.
- Skovron ML, Berkowitz GS, Lapinski RH, Kim JM, Chitkara U. Evaluation of early third-trimester ultrasound screening for intrauterine growth retardation. J Ultrasound Med. 1991 Mar;10(3):153-9. doi: 10.7863/jum.1991.10.3.153.
- Chang TC, Robson SC, Boys RJ, Spencer JA. Prediction of the small for gestational age infant: which ultrasonic measurement is best? Obstet Gynecol. 1992 Dec;80(6):1030-8.
- Kurmanavicius J, Burkhardt T, Wisser J, Huch R. Ultrasonographic fetal weight estimation: accuracy of formulas and accuracy of examiners by birth weight from 500 to 5000 g. J Perinat Med. 2004;32(2):155-61. doi: 10.1515/JPM.2004.028.
- Dudley NJ. A systematic review of the ultrasound estimation of fetal weight. Ultrasound Obstet Gynecol. 2005 Jan;25(1):80-9. doi: 10.1002/uog.1751.
- Rosati P, Exacoustos C, Caruso A, Mancuso S. Ultrasound diagnosis of fetal macrosomia. Ultrasound Obstet Gynecol. 1992 Jan 1;2(1):23-9. doi: 10.1046/j.1469-0705.1992.02010023.x.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Processus pathologiques
- Maladies urogénitales féminines et complications de la grossesse
- Poids
- Complications de grossesse
- Diabète sucré
- Maladies fœtales
- Troubles de la croissance
- Complications du diabète
- Diabète gestationnel
- Grossesse chez les diabétiques
- Poids à la naissance
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Retard de croissance fœtale
- Macrosomie fœtale
- Grossesse
- Reproduction
- Phénomènes physiologiques de la reproduction
- Phénomènes physiologiques reproducteurs et urinaires
- Parturition
Autres numéros d'identification d'étude
- AssiutFetalWT
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .