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期刊来源：JAMA

文献发表时间：2023.08.15

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2808328

关键点内容如下：

问题

对妊娠30至34周有分娩风险的孕妇静脉注射硫酸镁是否能降低其子女死亡或脑瘫的风险？

调查结果

这项随机临床试验包括1433名有早产风险的孕妇及其1679名婴儿，发现与安慰剂相比，暴露于硫酸镁的儿童在2岁矫正年龄时的死亡或脑瘫没有显著差异。

意义

妊娠30至34周早产前的硫酸镁并不能增加无脑瘫儿童的存活机会，尽管该研究检测效果的能力有限。

摘要内容如下：

重要性

妊娠小于30周的孕妇在出生前静脉注射硫酸镁可降低其子女死亡和脑瘫的风险。妊娠晚期的影响尚不清楚。

目的

确定在妊娠30至34周时给予硫酸镁是否可减少2年后的死亡或脑瘫。

研究设计和参与者

这项随机临床试验纳入了预计在妊娠30至34周分娩的孕妇，并于2012年1月至2018年4月在24家澳大利亚和新西兰医院进行。

干预

静脉注射硫酸镁（4 g）与安慰剂进行比较。

主要结果和措施

主要转归是死亡（死产、活产婴儿出院前死亡或出院后2岁矫正年龄前死亡）或2岁矫正年龄时的脑瘫（由儿科医生评估的运动功能丧失以及肌张力和肌力异常）。有36个次要结果评估了孕妇、婴儿和儿童的健康状况。

次要结果

在（平均年龄登记的1433名孕妇中，30.6[SD，6.6]岁；46名[3.2%]自认为是土著人或托雷斯海峡岛民，237名[16.5%]为亚洲人，82名[5.7%]为毛利人，61名[4.3%]是太平洋岛民，966名[67.4%]是白人）及其1679名婴儿，1365名（81%）后代（镁组691名和安慰剂组674名）被纳入主要结果分析。在矫正年龄为2岁时，死亡或脑瘫在镁组和安慰剂组之间没有显著差异（分别为3.3%[23/691名儿童]和2.7%[18/674名儿童]；风险差异，0.61%[95%CI，-1.27%至2.50%]；校正相对危险度[RR]，1.19[95%CI，0.65至2.18]）。主要结果的组成部分在两组之间没有差异。与安慰剂组相比，镁组新生儿发生呼吸窘迫综合征的可能性较小，分别为（34%[858例中的294例]和41%[821例中的334例]；校正RR，0.85[95%CI，0.76至0.95]）和慢性肺部疾病（5.6%[48/858]vs 8.2%[67/821]；调整RR，0.69[95%CI，0.48至0.99]出生住院期间的）。未发生严重不良事件；然而，与安慰剂相比，服用镁的孕妇发生不良事件的可能性更大，分别为（77%[531/690]和20%[136/667]；校正RR，3.76[95%CI，3.22-4.39]）。与安慰剂组相比，镁组中较少的孕妇进行剖宫产，分别为（56%[729例中的406例]和61%[704例中的427例]；校正RR，0.91[95%CI，0.84-0.99]），尽管镁组中有更多的严重产后出血（3.4%[729例中的25例]vs安慰剂组的1.7%[704例中的12例]；校正RR，1.98[95%CI，1.01-3.91]）。

结论和相关性

在妊娠30至34周的早产前静脉注射硫酸镁并不能提高2岁时无脑瘫的儿童存活率，尽管该研究在检测小的组间差异方面能力有限。

英文原文如下：

Key Points

Question  Does intravenous magnesium sulfate for pregnant individuals at risk of delivery between 30 and 34 weeks’ gestation reduce the risk of death or cerebral palsy in their children?

Findings  This randomized clinical trial including 1433 pregnant individuals at risk of preterm delivery and their 1679 infants found no significant difference in death or cerebral palsy at 2 years’ corrected age among children exposed to magnesium sulfate compared with placebo.

Meaning  Magnesium sulfate prior to preterm birth between 30 and 34 weeks’ gestation did not increase the chance of child survival without cerebral palsy, although this study had limited power to detect an effect.

Abstract

Importance  Intravenous magnesium sulfate administered to pregnant individuals before birth at less than 30 weeks’ gestation reduces the risk of death and cerebral palsy in their children. The effects at later gestational ages are unclear.

Objective  To determine whether administration of magnesium sulfate at 30 to 34 weeks’ gestation reduces death or cerebral palsy at 2 years.

Design, Setting, and Participants  This randomized clinical trial enrolled pregnant individuals expected to deliver at 30 to 34 weeks’ gestation and was conducted at 24 Australian and New Zealand hospitals between January 2012 and April 2018.

Intervention  Intravenous magnesium sulfate (4 g) was compared with placebo.

Main Outcomes and Measures  The primary outcome was death (stillbirth, death of a live-born infant before hospital discharge, or death after hospital discharge before 2 years’ corrected age) or cerebral palsy (loss of motor function and abnormalities of muscle tone and power assessed by a pediatrician) at 2 years’ corrected age. There were 36 secondary outcomes that assessed the health of the pregnant individual, infant, and child.

Results  Of the 1433 pregnant individuals enrolled (mean age, 30.6 [SD, 6.6] years; 46 [3.2%] self-identified as Aboriginal or Torres Strait Islander, 237 [16.5%] as Asian, 82 [5.7%] as Māori, 61 [4.3%] as Pacific, and 966 [67.4%] as White) and their 1679 infants, 1365 (81%) offspring (691 in the magnesium group and 674 in the placebo group) were included in the primary outcome analysis. Death or cerebral palsy at 2 years’ corrected age was not significantly different between the magnesium and placebo groups (3.3% [23 of 691 children] vs 2.7% [18 of 674 children], respectively; risk difference, 0.61% [95% CI, −1.27% to 2.50%]; adjusted relative risk [RR], 1.19 [95% CI, 0.65 to 2.18]). Components of the primary outcome did not differ between groups. Neonates in the magnesium group were less likely to have respiratory distress syndrome vs the placebo group (34% [294 of 858] vs 41% [334 of 821], respectively; adjusted RR, 0.85 [95% CI, 0.76 to 0.95]) and chronic lung disease (5.6% [48 of 858] vs 8.2% [67 of 821]; adjusted RR, 0.69 [95% CI, 0.48 to 0.99]) during the birth hospitalization. No serious adverse events occurred; however, adverse events were more likely in pregnant individuals who received magnesium vs placebo (77% [531 of 690] vs 20% [136 of 667], respectively; adjusted RR, 3.76 [95% CI, 3.22 to 4.39]). Fewer pregnant individuals in the magnesium group had a cesarean delivery vs the placebo group (56% [406 of 729] vs 61% [427 of 704], respectively; adjusted RR, 0.91 [95% CI, 0.84 to 0.99]), although more in the magnesium group had a major postpartum hemorrhage (3.4% [25 of 729] vs 1.7% [12 of 704] in the placebo group; adjusted RR, 1.98 [95% CI, 1.01 to 3.91]).

Conclusions and Relevance  Administration of intravenous magnesium sulfate prior to preterm birth at 30 to 34 weeks’ gestation did not improve child survival free of cerebral palsy at 2 years, although the study had limited power to detect small between-group differences.