Protocol for the prospective observational clinical study: estimation of fetal weight by MRI to PREdict neonatal MACROsomia (PREMACRO study) and small-for-gestational age neonates

INTRODUCTION: Macrosomia refers to growth beyond a specific threshold, regardless of gestational age. These fetuses are also frequently referred to as large for gestational age (LGA). Various cut-offs have been used but for research purposes, a cut-off above the 95th centile for birth weight is often preferred because it defines 90% of the population as normal weight. The use of centiles, rather than estimated weights, also accommodates preterm macrosomic infants, although most of the complications, maternal and fetal, arise during the delivery of large babies at term. This means that accurate identification of LGA fetuses (≥95th centile) may play an important role in guiding obstetric interventions, such as induction of labour or caesarean section. Traditionally, identification of fetuses suspected of macrosomia has been based on biometric measurements using two-dimensional (2D) ultrasound (US), yet this method is rather sub-optimal. We present a protocol (V.2.1, date 19 May 2016) for the estimation of fetal weight (EFW) by MRI to PREdict neonatal MACROsomia (PREMACRO study), which is a prospective observational clinical study designed to determine whether MRI at 36 + 0 to 36 + 6 weeks of gestation, as compared with 2D US, can improve the identification of LGA neonates ≥95th centile. METHODS AND ANALYSIS: All eligible women attending the 36-week clinic will be invited to participate in the screening study for LGA fetuses ≥95th centile and will undergo US-EFW and MRI-EFW within minutes of each other. From these estimations, a centile will be derived which will be compared with the centile of birth weight used as the gold standard. Besides birth weight, other pregnancy and neonatal outcomes will be collected and analysed. The first enrolment for the study was in May 2016. As of September 2018, 2004 women have been screened and recruited to the study. The study is due to end in April 2019. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the International Conference on Harmonisation for good clinical practice and the appropriate regulatory requirement(s). A favourable ethical opinion was obtained from the Ethics Committee of the University Hospital Brugmann, reference number CE2016/44. Results will be published in peer-reviewed journals and disseminated at international conferences. TRIAL REGISTRATION NUMBER: NCT02713568.