Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia
Comparison of the Accuracy of Fetal Weight Estimation Between Sonographic Vs. Magnetic Resonance Assessment
2 other identifiers
interventional
80
1 country
1
Brief Summary
The goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy. Pregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2025
CompletedFirst Submitted
Initial submission to the registry
February 14, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 13, 2028
March 27, 2025
March 1, 2025
2 years
February 14, 2025
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRI fetal weight estimation accuracy
gram
from enollment to Performing the MRI at 1 week
Study Arms (1)
suspected macrosomia
EXPERIMENTALsuspected macrosomia at term who will undergo sonographic and MRI fetal weight estimation
Interventions
all participant will undergo MRI fetal weight estimation
Eligibility Criteria
You may qualify if:
- singleton pregnancy at term, suspected fetal macrosomia,
You may not qualify if:
- fetal anomaly multiple pregnancy PROM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Galilee medical center
Nahariya, Israel
Related Publications (3)
Langer O, Berkus MD, Huff RW, Samueloff A. Shoulder dystocia: should the fetus weighing greater than or equal to 4000 grams be delivered by cesarean section? Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):831-7. doi: 10.1016/0002-9378(91)90424-p.
PMID: 1951539BACKGROUNDKadji C, Cannie MM, Kang X, Carlin A, Benjou Etchoua S, Resta S, Dutemeyer V, Abi-Khalil F, Mazzone E, Bevilacqua E, Jani JC. Fetal magnetic resonance imaging at 36 weeks predicts neonatal macrosomia: the PREMACRO study. Am J Obstet Gynecol. 2022 Feb;226(2):238.e1-238.e12. doi: 10.1016/j.ajog.2021.08.001. Epub 2021 Aug 4.
PMID: 34358479BACKGROUNDMalin GL, Bugg GJ, Takwoingi Y, Thornton JG, Jones NW. Antenatal magnetic resonance imaging versus ultrasound for predicting neonatal macrosomia: a systematic review and meta-analysis. BJOG. 2016 Jan;123(1):77-88. doi: 10.1111/1471-0528.13517. Epub 2015 Jul 29.
PMID: 26224221BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Amal shahin
Galilee Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Maternal Fetal Medicine Unit
Study Record Dates
First Submitted
February 14, 2025
First Posted
March 27, 2025
Study Start
February 13, 2025
Primary Completion (Estimated)
February 13, 2027
Study Completion (Estimated)
February 13, 2028
Last Updated
March 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR