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

Summary

Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. Historically, ultrasound has been used as a second line in such cases but the accuracy of this imaging modality in the mid- to late third trimester is also limited.

Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to guide obstetric interventions, when a fetus is small or large for dates. It frequently is the single most important component guiding interventions, such as induction of labour or Caesarean section.

Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected macrosomia in the 3rd trimester, the investigators believe that these estimates should not be used to make important obstetric decisions regarding mode and timing of delivery and that a more accurate method of assessment could produce better outcomes by restricting interventions to those foetuses at greatest risk. Some publications have already demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound

The goal of the present study is thus to compare the performance of magentic resonance imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the prediction of neonatal macrosomia.

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.

Sponsors & Collaborators

• Brugmann University Hospital

  lead OTHER

Principal Investigators

• Jacques Jani, MD · CHU Brugmann

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-03-08

Primary Completion

2020-03-10

Completion

2020-03-10

Countries

• Belgium

Study Locations