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RecruitingNCT06898892Updated Mar 27, 2025

Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia

An interventional study of Fetal MRI in Accuracy of Sonographic Vs MRI Fetal Weight Estimation, sponsored by Western Galilee Hospital-Nahariya. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Accuracy of Sonographic Vs MRI Fetal Weight Estimation

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Keywords

  • fetal weight estimation, accuracy
03

In context

Fetal Weight

17 studies on the registry are indexed under Fetal Weight; 7 are open to participants now.

Browse Fetal Weight studies →

Lead sponsor

Western Galilee Hospital-Nahariya is the lead sponsor of 89 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

singleton pregnancy at term, suspected fetal macrosomia,

Exclusion criteria

Exclusion Criteria:

  • fetal anomaly multiple pregnancy PROM
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    suspected macrosomia

    suspected macrosomia at term who will undergo sonographic and MRI fetal weight estimation

    Diagnostic Test: Fetal MRI

Interventions

  • Diagnostic testFetal MRI

    all participant will undergo MRI fetal weight estimation

06

What researchers measure

Primary outcomes

  1. MRI fetal weight estimation accuracy

    gram

    Time frame: from enollment to Performing the MRI at 1 week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 1951539 ↗
  • 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. PubMed 34358479 ↗
  • 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. PubMed 26224221 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Clinical study report

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2025
First posted
Mar 27, 2025
StartActual
Feb 13, 2025
Primary completionEst.
Feb 13, 2027
CompletionEst.
Feb 13, 2028
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06898892
Lead sponsor
Western Galilee Hospital-Nahariya
Responsible party
Dr. Maya Wolf (Head of Maternal Fetal Medicine Unit, Western Galilee Hospital-Nahariya) — Principal investigator
First posted
Mar 27, 2025
Start date
Feb 13, 2025
Primary completion
Feb 13, 2027 (estimated)
Completion
Feb 13, 2028 (estimated)
Last update
Mar 27, 2025

Study contacts

Maya Frank Wolf, Prof.
Contact
mayaw@gmc.gov.il
972-50-7887800
Amal shahin
principal investigator · Galilee Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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