Estimation of Fetal Weight by MR Imaging to PREdict Neonatal MACROsomia (PREMACRO Study)

NACompletedINTERVENTIONAL
Enrollment

2,413

Participants

Timeline

Start Date

March 8, 2016

Primary Completion Date

March 10, 2020

Study Completion Date

March 10, 2020

Conditions
Fetal Macrosomia
Interventions
OTHER

Ultrasound examination

"Prenatal Ultrasound examinations will be carried out using transabdominal sonography only by experienced consultants in MFM. Ultrasound-Estimated Fetal Weight will be obtained between 36.0-36.6 weeks of gestation, according to Hadlock et al.~Operators performing the Ultrasound-Estimated Fetal Weight will be blinded to the results of Magnetic Resonance-Estimated Fetal Weight. The participants, general practitioners, obstetricians and midwifes of the patients will be aware of the results of Ultrasound-Estimated Fetal Weight which will be used for clinical management.~For the primary outcome measure, macrosomia during Ultrasound-Estimated Fetal Weight will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be redefined as ≥ P90 or ≥ P99 based on Yudkin."

OTHER

Magnetic resonance examination

"MRI will be performed the same day as the Ultrasound examination, using a clinical 1.5T whole-body unit.~Operators performing Fetal Body Volume measurements will be blinded from Ultrasound-Estimated Fetal Weight results. Magnetic Resonance-Estimated Fetal Weight will be calculated using the equation 0,12+1,031\*Fetal Body Volume = MR imaging weight (g) developed by Baker.~General practitioners, obstetricians and midwifes of the patients will be blinded to the results of the Magnetic Resonance-Estimated Fetal Weight.~For the primary outcome measure, macrosomia will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be defined as ≥ P90 or ≥ P99."

Trial Locations (1)

1020

CHU Brugmann, Brussels

All Listed Sponsors
lead

Brugmann University Hospital

OTHER

NCT02713568 - Estimation of Fetal Weight by MR Imaging to PREdict Neonatal MACROsomia (PREMACRO Study) | Biotech Hunter | Biotech Hunter