Placental Growth Factor Led Management of the Small for Gestational Age Fetus: Randomised Controlled Feasibility Study.

Abstract

To determine the feasibility of a trial investigating the optimal timing for the birth of women with a suspected late preterm and term SGA baby using either angiogenic biomarker-led care or standard care. A mixed methods study including a randomised feasibility trial, interviews, questionnaires and economic analysis. Two tertiary maternity hospitals in the UK. Women with suspected SGA pregnancies between 32⁺⁰ weeks gestation and 37⁺⁶ weeks gestation. Women were randomised in a 3:1 ratio to biomarker-led care versus standard care. Biomarker tests were either revealed, with birth delayed until 40 weeks if normal (sFlt-1/PlGF < 38 pg/mL) and considered from 37 weeks if abnormal (sFlt-1/PlGF ≥ 38 pg/mL), or concealed alongside standard care. Primary outcome was the feasibility of the study measured through the recruitment rate and adherence. Secondary outcomes were the qualitative, proof-of-concept and economic analyses. Out of 128 women invited to participate 78 women were recruited giving a recruitment rate of 60.1% (95% confidence interval 52%-69%). Sixty-seven of the 78 women consented to randomisation. Sixteen parents and 12 clinicians were interviewed. Fourty parents completed a questionnaire. Participants, partners and clinicians viewed the study as acceptable but experienced challenges in participation and delivering the study. There were no significant adverse events or differences in neonatal outcomes. Collection of health economics data was feasible. The clinical, qualitative and economic results support the acceptability of utilising sFlt-1/PlGF to refine SGA management after 32⁺⁰ weeks but the feasibility is less certain.