Project publication: Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial

• Published in: Health technology assessment (Winchester, England) Vol. 27; no. 28; pp. 27 - 28
• Main Authors: Chappell, Lucy C, Brocklehurst, Peter, Green, Marcus, Hardy, Pollyanna, Hunter, Rachael, Beardmore-Gray, Alice, Bowler, Ursula, Brockbank, Anna, Chiocchia, Virginia, Cox, Alice, Duhig, Kate, Fleminger, Jessica, Gill, Carolyn, Greenland, Melanie, Hendy, Eleanor, Kennedy, Ann, Leeson, Paul, Linsell, Louise, McCarthy, Fergus P, O’Driscoll, Jamie, Placzek, Anna, Poston, Lucilla, Robson, Stephen, Rushby, Pauline, Sandall, Jane, Scholtz, Laura, Seed, Paul T, Sparkes, Jenie, Stanbury, Kayleigh, Tohill, Sue, Thilaganathan, Basky, Townend, John, Juszczak, Edmund, Marlow, Neil, Shennan, Andrew
• Format: Journal Article
• Language: English
• Published: 01.12.2023
• ISSN: 2046-4924; 2046-4924
• DOI: 10.3310/MSME8078

Objective We evaluated the best time to initiate delivery in late preterm pre-eclampsia in order to optimise long-term infant and maternal outcomes. Design Parallel-group, non-masked, randomised controlled trial. Setting 46 UK maternity units. Population Women with pre-eclampsia between 34 +0 and 36 +6 weeks’ gestation, without severe disease, were randomised to planned delivery or expectant management. Primary long-term outcome Infant neurodevelopmental outcome at 2 years of age, using the PARCA-R (Parent Report of Children’s Abilities-Revised) composite score. Results Between 29 September 2014 and 10 December 2018, 901 women were enrolled in the trial, with 450 allocated to planned delivery and 451 to expectant management. At 2-year follow-up, the intention-to-treat analysis population included 276 women (290 infants) allocated to planned delivery and 251 women (256 infants) to expectant management. The mean composite standardised PARCA-R scores were 89.5 [standard deviation (SD) 18.2] in the planned delivery group and 91.9 (SD 18.4) in the expectant management group, with an adjusted mean difference of −2.4 (95% CI −5.4 to 0.5) points. Conclusion In infants of women with late preterm pre-eclampsia, average neurodevelopmental assessment at 2 years lies within the normal range, regardless of whether planned delivery or expectant management is pursued. Because of lower than anticipated follow-up, there was limited power to demonstrate these scores were not different, but the small between-group difference in PARCA-R scores is unlikely to be clinically important.