The UmbilicoCerebral Ratio in late preterm Fetal Growth Restriction
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Does, in late preterm fetuses identified as Small-for-Gestational-Age (SGA), timing of delivery based on abnormal UmbilicoCerebral Ratio (UCR) improve neurodevelopmental outcome?
Cohort of women with identified SGA pregnancies with a nested RCT in fetuses with abnormal UCR.
Cohort: Singleton pregnancies with identified SGA (EFW/FAC <p10), 32-37 weeks gestation
RCT: Identified SGA baby and abnormal UCR (>0.8), 34-37 weeks gestation
Delivery from 34 weeks when UCR is abnormal and fetal growth is severely abnormal (EFW/FAC below p3) and delivery from 36 weeks when UCR is abnormal and fetal growth is mildly abnormal (EFW/FAC p3-p10).
Delivery as per local protocol, usually from 38-40 weeks or later unless worsening of maternal/fetal condition prompts earlier delivery
Primary: 7-point average difference MDI/PDI Bayley-3 at 2 years
Secondary: composite outcome of neonatal morbidity appropriate for late preterm gestations, perinatal mortality, mode of delivery, maternal quality of life, costs.
With an alpha of 0.05 and a beta of 0.8, calculated sample size is 74 for each arm of the nested RCT. Accounting for 20% loss to follow-up of randomized fetuses 185 women will be needed for the RCT in total. Assuming 20% incidence of abnormal UCR within the cohort of SGA-fetuses and accounting for an inclusion rate in the trial of 60% we calculate to need a cohort of 1542 patients.
01-2018 until 01-2020 inclusion period in cohort and nested RCT.
01-2020 until 01-2022 follow-up period for primary outcome
Dr. J.W. Ganzevoort, Gynaecoloog-Perinatoloog, Academisch Medisch Centrum
Dr. S.J. Gordijn, Gynaecoloog-Perinatoloog, Universitair Medisch Centrum Groningen
Maddy Smies, Researcher, Academisch Medisch Centrum