Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.
National Tsing-Hua University, Hsinchu, Taiwan.
BMC Med. 2023 Oct 31;21(1):413. doi: 10.1186/s12916-023-03125-w.
Antenatal corticosteroids are considered the standard of care for pregnant women at risk for preterm birth, but studies examining their potential risks are scarce. We aimed to estimate the associations of antenatal corticosteroids with three severe adverse events: sepsis, heart failure, and gastrointestinal bleeding, in pregnant women.
Of 2,157,321 pregnant women, 52,119 at 24 weeks 0/7 days to 36 weeks 6/7 days of gestation were included in this self-controlled case series study during the study period of 2009-2018. We estimated incidence rates of three severe adverse events: sepsis, heart failure, and gastrointestinal bleeding. Conditional Poisson regression was used to calculate incidence rate ratios (IRRs) for comparing incidence rates of the adverse events in each post-treatment period compared to those during the baseline period among pregnant women exposed to a single course of antenatal corticosteroid treatment.
Among 52,119 eligible participants who received antenatal corticosteroid treatment, the estimated incidence rates per 1000 person-years were 0.76 (95% confidence interval (CI): 0.69-0.83) for sepsis, 0.31 (95% CI: 0.27-0.36) for heart failure, and 11.57 (95% CI: 11.27-11.87) for gastrointestinal bleeding. The IRRs at 5 ~ 60 days after administration of antenatal corticosteroids were 5.91 (95% CI: 3.10-11.30) for sepsis and 4.45 (95% CI: 2.63-7.55) for heart failure, and 1.26 (95% CI: 1.02-1.55) for gastrointestinal bleeding; and the IRRs for days 61 ~ 180 were 2.00 (95% CI: 1.01-3.96) for sepsis, 3.65 (95% CI: 2.14-6.22) for heart failure, and 1.81 (95% CI: 1.56-2.10) for gastrointestinal bleeding.
This nationwide population-based study suggests that a single course of antenatal corticosteroids is significantly associated with a 1.3- to 5.9-fold increased risk of sepsis, heart failure, and gastrointestinal bleeding in pregnant women. Maternal health considerations, including recommendations for adverse event monitoring, should be included in future guidelines for antenatal corticosteroid treatment.
产前皮质类固醇被认为是有早产风险的孕妇的标准治疗方法，但研究其潜在风险的研究很少。我们旨在评估产前皮质类固醇与三种严重不良事件（败血症、心力衰竭和胃肠道出血）在孕妇中的关联。
在 2009 年至 2018 年的研究期间，纳入了 2157321 名孕妇，其中 52119 名孕妇在妊娠 24 周 0/7 天至 36 周 6/7 天。我们估计了三种严重不良事件（败血症、心力衰竭和胃肠道出血）的发生率。采用条件泊松回归计算了在接受单次产前皮质类固醇治疗的孕妇中，与基线期相比，每个治疗后期间不良事件发生率的发病率比（IRR）。
在 52119 名符合条件的接受产前皮质类固醇治疗的参与者中，每 1000 人年的估计发生率分别为败血症 0.76（95%置信区间：0.69-0.83）、心力衰竭 0.31（95%置信区间：0.27-0.36）和胃肠道出血 11.57（95%置信区间：11.27-11.87）。在产前皮质类固醇给药后 560 天，败血症的 IRR 为 5.91（95%置信区间：3.10-11.30），心力衰竭为 4.45（95%置信区间：2.63-7.55），胃肠道出血为 1.26（95%置信区间：1.02-1.55）；在 61180 天，败血症的 IRR 为 2.00（95%置信区间：1.01-3.96），心力衰竭为 3.65（95%置信区间：2.14-6.22），胃肠道出血为 1.81（95%置信区间：1.56-2.10）。
这项基于全国人口的研究表明，单次产前皮质类固醇治疗与孕妇败血症、心力衰竭和胃肠道出血的风险增加 1.3 至 5.9 倍显著相关。未来的产前皮质类固醇治疗指南应考虑产妇健康问题，包括对不良事件监测的建议。
