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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

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the PHOENIX Study Group

Original languageEnglish
Pages (from-to)1654-1663
Number of pages10
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume129
Issue number10
DOIs
Accepted/In press2022
PublishedSep 2022

Bibliographical note

Funding Information: We thank the independent Trial Steering Committee: chair, Jane Norman (University of Bristol); members, Simon Gates (University of Birmingham), Alison Leaf (University Hospital Southampton NHS Foundation Trust), Katie Lean (Oxford University Hospitals NHS Foundation Trust), Stavros Petrou (University of Oxford) and Jacqui Williams (lay member). We also thank the independent Data Monitoring Committee: chair, Diana Elbourne (London School of Hygiene & Tropical Medicine); members, Phillip Bennett (Imperial College London) and Jon Dorling (Dalhousie University, Halifax). We also thank all the participating women, site research midwives and doctors for their contribution to the trial. Funding Information: The study was funded by the UK’s National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (12/25/03) following external peer review, and with involvement of public representative panel members. The funder of the study had no role in the study design, data collection, analysis, interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The trial was prospectively registered with the ISRCTN registry (ISRCTN01879376). Publisher Copyright: © 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

King's Authors

Abstract

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: Forty-six maternity units in the UK. Population: Women with pre-eclampsia between 34+0 and 36+6 weeks of gestation, without severe disease, were randomised to planned delivery or expectant management. Main outcome measures: Infant neurodevelopmental outcome at 2 years of age, using the Parent Report of Children’s Abilities – Revised (PARCA-R) composite score. Results: Between 29 September 2014 and 10 December 2018, 901 women were enrolled in the trial, with 450 women allocated to planned delivery and 451 women allocated to expectant management. At the 2-year follow-up, the intention-to-treat analysis population included 276 women (290 infants) allocated to planned delivery and 251 women (256 infants) allocated to expectant management. The mean composite standardised PARCA-R scores were 89.5 (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 points (95% CI −5.4 to 0.5 points). Conclusions: In infants of women with late preterm pre-eclampsia, the average neurodevelopmental assessment at 2 years lies within the normal range, regardless of whether planned delivery or expectant management was pursued. With the lower than anticipated follow-up rate there was limited power to demonstrate that these scores did not differ, but the small between-group difference in PARCA-R scores is unlikely to be clinically important.

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