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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

Beardmore‐Gray, Alice; Greenland, Melanie; Linsell, Louise; Juszczak, Edmund; Hardy, Pollyanna; Placzek, Anna; Hunter, Rachael; Sparkes, Jenie; Green, Marcus; Shennan, Andrew; Marlow, Neil; Chappell, Lucy C.; the PHOENIX Study Group

Authors

Alice Beardmore‐Gray

Melanie Greenland

Louise Linsell

ED JUSZCZAK Ed.Juszczak@nottingham.ac.uk
Professor of Clinical Trials Andstatistics in Medicine

Pollyanna Hardy

Anna Placzek

Rachael Hunter

Jenie Sparkes

Marcus Green

Andrew Shennan

Neil Marlow

Lucy C. Chappell

the PHOENIX Study Group



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.

Citation

Beardmore‐Gray, A., Greenland, M., Linsell, L., Juszczak, E., Hardy, P., Placzek, A., …the PHOENIX Study Group. (2022). 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. BJOG: An International Journal of Obstetrics and Gynaecology, https://doi.org/10.1111/1471-0528.17167

Journal Article Type Article
Acceptance Date Feb 12, 2022
Online Publication Date May 12, 2022
Publication Date May 12, 2022
Deposit Date May 13, 2022
Publicly Available Date May 13, 2022
Journal BJOG: An International Journal of Obstetrics & Gynaecology
Print ISSN 1470-0328
Electronic ISSN 1471-0528
Publisher Wiley
Peer Reviewed Peer Reviewed
DOI https://doi.org/10.1111/1471-0528.17167
Keywords Obstetrics and Gynecology
Public URL https://nottingham-repository.worktribe.com/output/8048996
Publisher URL https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17167

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