Journal article
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
- Abstract:
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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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 1.5MB, Terms of use)
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(Preview, Supplementary materials, pdf, 326.9KB, Terms of use)
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- Publisher copy:
- 10.1111/1471-0528.17167
Authors
- Publisher:
- Wiley
- Journal:
- BJOG: An International Journal of Obstetrics and Gynaecology More from this journal
- Volume:
- 129
- Issue:
- 10
- Pages:
- 1654-1663
- Publication date:
- 2022-05-12
- Acceptance date:
- 2022-02-12
- DOI:
- EISSN:
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1471-0528
- ISSN:
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1470-0328
- Pmid:
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35362666
- Language:
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English
- Keywords:
- Pubs id:
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1250545
- Local pid:
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pubs:1250545
- Deposit date:
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2022-06-01
- ARK identifier:
Terms of use
- Copyright holder:
- Beardmore-Gray et al.
- Copyright date:
- 2022
- Rights statement:
- ©2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
- Licence:
- CC Attribution (CC BY)
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