Clinical trial NCT06898892: Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia
Official title: Comparison of the Accuracy of Fetal Weight Estimation Between Sonographic Vs. Magnetic Resonance Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accuracy of Sonographic Vs MRI Fetal Weight Estimation
Keywords: fetal weight estimation, accuracy
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2025-03-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed description: 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 inclusion criteria: singleton pregnancies at term, suspected fetal macrosomia (\>4000 gr in non GDM and \>3800 gr. in GDM cases exclusion criteria-fetal anomaly, PPROM, multiple gestation The radiologist and the sonographer will be blinded to the fetal weight estimation and to the other estimation done

Eligibility criteria: Inclusion Criteria:

singleton pregnancy at term, suspected fetal macrosomia,

Exclusion Criteria:

* fetal anomaly multiple pregnancy PROM

Primary outcomes:
measure: MRI fetal weight estimation accuracy
timeFrame: from enollment to Performing the MRI at 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariyya
country: Israel
facility: Galilee medical center
Study officials:
affiliation: Galilee Medical Center
name: Amal shahin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kadji 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.
citation: Malin 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.