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在一家高容量的三级保健中心实施产前晚期早产儿皮质类固醇方案。

Implementation of an antenatal late-preterm corticosteroid protocol at a high-volume tertiary care center.

机构信息

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.

Department of Pediatrics, Division of Neonatology, Northwestern University Feinberg School of Medicine, Chicago, IL.

出版信息

Am J Obstet Gynecol MFM. 2020 Feb;2(1):100076. doi: 10.1016/j.ajogmf.2019.100076. Epub 2019 Dec 17.

Abstract

BACKGROUND

Since publication of the sentinel antenatal late preterm steroids clinical trial, the use of antenatal steroids has become a routine aspect of the management of pregnancies at risk for late preterm delivery. However, in practice, the administration of antenatal corticosteroids in the late preterm period is widely varied across provider and institution, and the process of implementation of this new practice as well as outcomes associated with implementation are not well understood.

OBJECTIVE

The objective was to evaluate institutional adherence to an antenatal late preterm corticosteroid protocol and to assess neonatal outcomes associated with its introduction.

STUDY DESIGN

This is a retrospective cohort study of all women with singleton pregnancies admitted between 34 to 36 5/7 weeks who presented in the year before ("pre-protocol": November 2012 to October 2013) and after implementation ("post-protocol": April 2016 to March 2017). The protocol recommends corticosteroid administration to women 34 to 36 5/7 weeks gestation at risk for preterm birth who have not received prior corticosteroids. Women with fetal anomalies or pregestational or gestational diabetes were excluded from analysis. The frequency with which eligible women received corticosteroids and ineligible women were appropriately excluded (adherence) was calculated on a monthly basis. Neonatal outcomes of interest were hypoglycemia, receipt of dextrose, birth weight, 5 minute Apgar less than 7, receipt of surfactant, respiratory distress syndrome, transient tachypnea of the newborn, neonatal intensive care unit length of stay, intraventricular hemorrhage, necrotizing enterocolitis, culture positive sepsis, bronchopulmonary dysplasia, and death. Bivariable and multivariable analyses were used to compare neonatal outcomes between 1) all women in the post-protocol cohort to those in the pre-protocol cohort and 2) only women who received adherent care in the post-protocol cohort to all women in the pre-protocol cohort.

RESULTS

A total of 452 women were included in the pre-protocol cohort and 451 in the post-protocol cohort. The majority of the post-protocol women (N=366, 81.2%) received adherent care. Women in both cohorts were similar with the exception that women in the post-protocol cohort were more likely to be nulliparous (p=0.013). Compared to the pre-protocol period, neonates of women in the post-protocol period had significantly higher odds of hypoglycemia <50 mg/dL in the first 24 hours of life (aOR 1.37, 95% CI 1.05-1.80), without improvements in respiratory outcomes. Results were similar when restricting the analysis to only women in the post-protocol cohort who received care adherent care (glucose <50 mg/dL: aOR 1.52, 95% CI 1.14-2.03). No differences in composite respiratory morbidity or other neonatal outcomes were observed.

CONCLUSION

Uptake of a new institutional protocol for antenatal late preterm corticosteroids was rapid. Compared with historic controls, neonates exposed to antenatal late preterm corticosteroid experienced increased odds of hypoglycemia, without significant improvements in respiratory morbidities.

摘要

背景

自发表哨兵产前晚期早产儿皮质类固醇临床试验以来,产前皮质类固醇的使用已成为晚期早产儿分娩风险管理的常规内容。然而,在实践中,提供者和机构之间在晚期早产儿期间使用产前皮质类固醇的情况差异很大,并且对这种新实践的实施过程以及与实施相关的结果了解甚少。

目的

评估机构对产前晚期早产儿皮质类固醇方案的依从性,并评估其引入与新生儿结局的关系。

研究设计

这是一项对所有在 34 至 36 5/7 周之间入院的单胎妊娠妇女进行的回顾性队列研究,这些妇女在实施前(“方案前”:2012 年 11 月至 2013 年 10 月)和实施后(“方案后”:2016 年 4 月至 2017 年 3 月)。该方案建议对有早产风险且未接受过皮质类固醇的 34 至 36 5/7 周妊娠的妇女给予皮质类固醇。有胎儿异常或孕前或妊娠期糖尿病的妇女被排除在分析之外。每月计算有资格接受皮质类固醇的妇女和无资格接受皮质类固醇的妇女的接受率(依从性)。感兴趣的新生儿结局包括低血糖、接受葡萄糖、出生体重、5 分钟时 Apgar 评分低于 7、接受表面活性剂、呼吸窘迫综合征、新生儿暂时性呼吸急促、新生儿重症监护病房住院时间、颅内出血、坏死性小肠结肠炎、培养阳性败血症、支气管肺发育不良和死亡。使用单变量和多变量分析比较了 1)方案后队列中的所有妇女与方案前队列中的妇女,2)仅方案后队列中接受依从性护理的妇女与方案前队列中的所有妇女之间的新生儿结局。

结果

共有 452 名妇女被纳入方案前队列,451 名妇女被纳入方案后队列。在后方案队列中,大多数妇女(N=366,81.2%)接受了依从性护理。两个队列中的妇女都相似,只是在后方案队列中的妇女更可能是初产妇(p=0.013)。与方案前时期相比,方案后时期妇女的新生儿在生命的头 24 小时内发生低血糖的可能性显著更高(aOR 1.37,95%CI 1.05-1.80),但呼吸结局并无改善。当将分析仅限于仅在后方案队列中接受依从性护理的妇女时,结果相似(血糖<50mg/dL:aOR 1.52,95%CI 1.14-2.03)。未观察到复合呼吸发病率或其他新生儿结局的差异。

结论

新的产前晚期早产儿皮质类固醇机构方案的实施速度很快。与历史对照相比,接受产前晚期早产儿皮质类固醇治疗的新生儿发生低血糖的几率增加,但呼吸发病率没有显著改善。

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