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

NCT ID: NCT06898892

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2028-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Accuracy of Sonographic Vs MRI Fetal Weight Estimation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

suspected macrosomia

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

Group Type EXPERIMENTAL

Fetal MRI

Intervention Type DIAGNOSTIC_TEST

all participant will undergo MRI fetal weight estimation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fetal MRI

all participant will undergo MRI fetal weight estimation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

singleton pregnancy at term, suspected fetal macrosomia,

Exclusion Criteria

* fetal anomaly multiple pregnancy PROM
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Maya Wolf

Head of Maternal Fetal Medicine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amal shahin

Role: PRINCIPAL_INVESTIGATOR

Galilee Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Galilee medical center

Nahariya, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maya Frank Wolf, Prof.

Role: CONTACT

972-50-7887800

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 1951539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34358479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26224221 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Galilee medical center

Identifier Type: OTHER

Identifier Source: secondary_id

0249-24-NHR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fetal Brain Ultrasound
NCT06410391 COMPLETED