Comparison of Sonographic and MRI Weight Estimation in Fe... | NCT06898892

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

NCT06898892

Sponsor

Western Galilee Hospital-Nahariya

Status

Recruiting

Last Update Posted

Mar 27, 2025Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Accuracy of Sonographic Vs MRI Fetal Weight Estimation

Interventions

Fetal MRI

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Galilee medical center	Other Identifier	Bar Ilan University

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2025Actual

Primary Completion Date

Feb 13, 2027Estimated

Completion Date

Feb 13, 2028Estimated

First Submitted Date

Feb 14, 2025

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Mar 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Mar 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Maya Wolf, Head of Maternal Fetal Medicine Unit, Western Galilee Hospital-NahariyaPrincipal Investigator

Lead Sponsor

Western Galilee Hospital-NahariyaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
suspected macrosomia	Experimental	suspected macrosomia at term who will undergo sonographic and MRI fetal weight estimation	Diagnostic Test: Fetal MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fetal MRI	Diagnostic Test	all participant will undergo MRI fetal weight estimation	suspected macrosomia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI fetal weight estimation accuracy	gram	from enollment to Performing the MRI at 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

singleton pregnancy at term, suspected fetal macrosomia,

Exclusion Criteria:

fetal anomaly multiple pregnancy PROM

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maya Frank Wolf, Prof.	Contact	972-50-7887800		mayaw@gmc.gov.il

Overall Officials

Name	Affiliation	Role
Amal shahin	Galilee Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Galilee medical center	Recruiting	Nahariya			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1951539	Background	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.
34358479	Background	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.