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.
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.
复制标题
DOI：
10.1111/1471-0528.17167
复制
发表时间：
2022-09
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
我们评估了晚期早产先兆子痫开始分娩的最佳时间，以优化婴儿和产妇的长期结局。平行组、非掩蔽、随机对照试验。英国有 46 个产科单位。妊娠 34+0 至 36+6 周患有先兆子痫且无严重疾病的女性被随机分配接受计划分娩或期待治疗。使用《儿童能力家长报告 - 修订版》(PARCA-R) 综合评分计算 2 岁时婴儿的神经发育结果。 2014年9月29日至2018年12月10日期间，共有901名妇女参加了试验，其中450名妇女分配至计划分娩，451名妇女分配至待产管理。在 2 年随访中，意向治疗分析人群包括分配至计划分娩的 276 名妇女（290 名婴儿）和分配至期待治疗的 251 名妇女（256 名婴儿）。计划分娩组的平均复合标准化 PARCA-R 评分为 89.5 (SD 18.2)，期待管理组为 91.9 (SD 18.4)，调整后的平均差为 -2.4 分（95% CI -5.4 至 0.5 分）。在患有晚期早产先兆子痫的妇女中，无论是否进行计划分娩或期待治疗，2岁时的平均神经发育评估都在正常范围内。由于随访率低于预期，证明这些评分没有差异的能力有限，但 PARCA-R 评分的组间微小差异不太可能具有临床重要性。 链接文章：Susan Walker 和 Brett Manley 在本期第 1664‐1665 页对本文进行了评论。要查看此简短评论，请访问 https://doi.org/10.1111/1471-0528.17165。
We evaluated the best time to initiate delivery in late preterm pre‐eclampsia in order to optimise long‐term infant and maternal outcomes. Parallel‐group, non‐masked, randomised controlled trial. Forty‐six maternity units in the UK. Women with pre‐eclampsia between 34+0 and 36+6 weeks of gestation, without severe disease, were randomised to planned delivery or expectant management. Infant neurodevelopmental outcome at 2 years of age, using the Parent Report of Children’s Abilities – Revised (PARCA‐R) composite score. 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). 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. Linked article: This article is commented on by Susan Walker and Brett Manley, pp. 1664‐1665 in this issue. To view this minicommentary visit https://doi.org/10.1111/1471-0528.17165.