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产前晚期早产儿皮质激素试验:双胎妊娠和孕前糖尿病患儿呼吸系统结局的中断时间序列分析。

Post Antenatal Late Preterm Steroids trial: interrupted time series analysis of respiratory outcomes in twin and pregestational diabetes.

机构信息

Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA (Drs Onishi, Saade, and Kawakita).

Department of Business Management, National Sun Yat-Sen University, Kaohsiung, Taiwan (Dr Huang).

出版信息

Am J Obstet Gynecol MFM. 2023 Aug;5(8):101041. doi: 10.1016/j.ajogmf.2023.101041. Epub 2023 Jun 7.

Abstract

BACKGROUND

The Antenatal Late Preterm Steroids trial found that corticosteroid administration decreased respiratory complications by 20% among late preterm singleton deliveries. After the Antenatal Late Preterm Steroids trial, corticosteroid administration increased by 76% among twin pregnancies and 113% among singleton pregnancies complicated by pregestational diabetes mellitus compared with expected rates based on the pre-Antenatal Late Preterm Steroids trial trend. However, the effect of corticosteroids on twin pregnancies and pregnancies complicated by pregestational diabetes mellitus is not well studied, as the Antenatal Late Preterm Steroids trial excluded twin pregnancies and pregnancies complicated by pregestational diabetes mellitus.

OBJECTIVE

This study aimed to examine the change in the incidence rate of immediate assisted ventilation use and ventilation use for more than 6 hours among 2 populations after the dissemination of the Antenatal Late Preterm Steroids trial at the population level.

STUDY DESIGN

This study was a retrospective analysis of publicly available US birth certificate data. The study period was from August 1, 2014, to April 30, 2018. The dissemination period of the Antenatal Late Preterm Steroids trial was from February 2016 to October 2016. Population-based interrupted time series analyses were performed for 2 target populations: (1) twin pregnancies not complicated by pregestational diabetes mellitus and (2) singleton pregnancies complicated by pregestational diabetes mellitus. For both target populations, analyses were limited to individuals who delivered nonanomalous live neonates between 34 0/7 and 36 6/7 weeks of gestation (vaginal or cesarean delivery). As a sensitivity analysis, a total of 23 placebo tests were conducted before (5 tests) and after (18 tests) the dissemination period.

RESULTS

For the analysis of late preterm twin deliveries, 191,374 individuals without pregestational diabetes mellitus were identified. For the analysis of late preterm singleton pregnancy with pregestational diabetes mellitus, 21,395 individuals were identified. After the dissemination period, the incidence rate of immediate assisted ventilation use for late preterm twin deliveries was significantly lower than the expected value based on the pre-Antenatal Late Preterm Steroids trial trend (11.6% observed vs 13.0% expected; adjusted incidence rate ratio, 0.87; 95% confidence interval, 0.78-0.97). The incidence rate of ventilation use for more than 6 hours among late preterm twin deliveries did not change significantly after the dissemination of the Antenatal Late Preterm Steroids trial. A significant increase in the incidence rate of immediate assisted ventilation use and ventilation use for more than 6 hours was found among singleton pregnancies with pregestational diabetes mellitus. However, the results of placebo tests suggested that the increase in incidence was not necessarily due to the dissemination period of the Antenatal Late Preterm Steroids trial.

CONCLUSION

The dissemination of the Antenatal Late Preterm Steroids trial was associated with decreased incidence of immediate assisted ventilation use, but no change in ventilation use for more than 6 hours, among late preterm twin deliveries in the United States. In contrast, the incidence of neonatal respiratory outcomes among singleton deliveries with pregestational diabetes mellitus did not decrease after the dissemination of the Antenatal Late Preterm Steroids trial.

摘要

背景

产前晚期早产儿类固醇试验发现,皮质类固醇的使用使晚期早产儿的单胎分娩的呼吸并发症减少了 20%。产前晚期早产儿类固醇试验后,与基于产前晚期早产儿类固醇试验前趋势的预期率相比,双胞胎妊娠中皮质类固醇的使用增加了 76%,而在有孕前糖尿病的单胎妊娠中增加了 113%。然而,皮质类固醇对双胞胎妊娠和有孕前糖尿病的妊娠的影响尚未得到很好的研究,因为产前晚期早产儿类固醇试验排除了双胞胎妊娠和有孕前糖尿病的妊娠。

目的

本研究旨在从人群水平上研究在产前晚期早产儿类固醇试验传播后,2 个人群中立即辅助通气使用和通气使用超过 6 小时的发生率变化。

研究设计

这是一项对美国公开出生证明数据的回顾性分析。研究期间为 2014 年 8 月 1 日至 2018 年 4 月 30 日。产前晚期早产儿类固醇试验的传播期为 2016 年 2 月至 2016 年 10 月。对 2 个目标人群进行了基于人群的中断时间序列分析:(1)不伴有孕前糖尿病的双胎妊娠和(2)伴有孕前糖尿病的单胎妊娠。对于这两个目标人群,分析仅限于在 34 0/7 至 36 6/7 周妊娠(阴道或剖宫产)期间分娩非畸形活新生儿的个体。作为敏感性分析,在传播期前后(5 次试验前和 18 次试验后)共进行了 23 次安慰剂测试。

结果

对于晚期早产儿双胎分娩的分析,确定了 191374 名没有孕前糖尿病的个体。对于伴有孕前糖尿病的晚期早产儿单胎妊娠的分析,确定了 21395 名个体。在传播期后,晚期早产儿双胎分娩中立即辅助通气使用的发生率明显低于基于产前晚期早产儿类固醇试验前趋势的预期值(11.6%观察到的 vs 13.0%预期;调整后的发病率比为 0.87;95%置信区间为 0.78-0.97)。晚期早产儿双胎分娩中通气使用超过 6 小时的发生率在产前晚期早产儿类固醇试验传播后没有明显变化。伴有孕前糖尿病的单胎妊娠中立即辅助通气使用和通气使用超过 6 小时的发生率显著增加。然而,安慰剂测试的结果表明,发生率的增加不一定是由于产前晚期早产儿类固醇试验的传播期。

结论

产前晚期早产儿类固醇试验的传播与美国晚期早产儿双胎分娩中立即辅助通气使用的发生率降低有关,但通气使用超过 6 小时的发生率没有变化。相比之下,在产前晚期早产儿类固醇试验传播后,有孕前糖尿病的单胎妊娠中新生儿呼吸结局的发生率并没有下降。

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