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Planned delivery or expectant management for late preterm pre-eclampsia: a randomised controlled trial (PHOENIX trial).

Lucy C Chappell,1 Peter Brocklehurst,2 Marcus Green,3 Rachael Hunter,4 Pollyanna Hardy,2 Edmund Juszczak,5 
1: King’s College London, 2: University of Birmingham, 3: Action on Pre-eclampsia, 4: University College London, 5: University of Oxford 
In women with late preterm pre-eclampsia (between 34 and 37 weeks of gestation), the optimal time to initiate delivery is unclear, as limitation of maternal disease progression needs to be balanced against complications for the infant related to ongoing expectant management or planned delivery. We hypothesised that planned delivery would reduce maternal morbidity without worse outcomes for the infant. 
In this parallel-group, non-masked, multi-centre, randomised controlled trial, we compared planned delivery against expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure ≥160 mmHg. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission. Analyses were by intention to treat. ISRCTN 01879376. REC 13/SC/0645. Funder: NIHR HTA. 
Between 29.09.2014 and 10.12.2018, 901 women were recruited across 46 maternity units. 450 women (448 women and 471 infants analysed) were randomly allocated to planned delivery, and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (64.7%) compared to the expectant management group (75.3%); adjusted risk ratio 0.86 (95% CI 0.79 to 0.94); p<0.01. The incidence of the co-primary perinatal outcome (composite of perinatal deaths, and neonatal unit admissions) was significantly higher in the planned delivery group (41.8%) compared to the expectant management group (33.5%); adjusted risk ratio 1.26 (95% CI 1.08 to 1.47); p<0.01. There were no perinatal deaths in the trial. Spontaneous vaginal delivery was more common in the planned delivery group (aRR: 1.21 (95% CI 1.04 to 1.41)). The principal recorded indication for neonatal unit admission was ‘prematurity’. There were no significant differences in the proportions requiring supplementary oxygen or additional respiratory support, and no differences in intensity of neonatal care or length of stay for the infant. There were nine serious adverse events in the planned delivery group compared to 12 in the expectant management group. 
Planned delivery reduces maternal morbidity and severe hypertension, with more neonatal unit admissions related to prematurity, but no indicators of greater neonatal morbidity, compared to expectant management. 

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