Department of Obstetrics, Gynecology, and Reproductive Biology, the Institute of Technology Assessment, Department of Radiology, and the Division of Biostatistics, Massachusetts General Hospital, and the Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, San Diego, California; the Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; the Department of Obstetrics and Gynecology, Columbia University, New York, New York; and the Department of Obstetrics and Gynecology, University of South Florida, Tampa, Florida.
Obstet Gynecol. 2024 Dec 1;144(6):747-754. doi: 10.1097/AOG.0000000000005756. Epub 2024 Oct 10.
To estimate the effect of late preterm antenatal steroids on the risk of respiratory morbidity among subgroups of patients on the basis of the planned mode of delivery and gestational age at presentation.
This was a secondary analysis of the ALPS (Antenatal Late Preterm Steroid) Trial, a multicenter trial conducted within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network of individuals with singleton gestations and without preexisting diabetes who were at high risk for late preterm delivery (34-36 weeks of gestation). We fit binomial regression models to estimate the risk of respiratory morbidity, with and without steroid administration, by gestational age and planned mode of delivery at the time of presentation. We assumed a homogeneous effect of steroids on the log-odds scale, as was reported in the ALPS trial. The primary outcome was neonatal respiratory morbidity, as defined in the ALPS Trial.
The analysis included 2,825 patients at risk for late preterm birth. The risk of respiratory morbidity varied significantly by planned mode of delivery (adjusted risk ratio [RR] 1.90, 95% CI, 1.55-2.33 for cesarean delivery vs vaginal delivery) and week of gestation at presentation (adjusted RR 0.56, 95% CI, 0.50-0.63). For those planning cesarean delivery and presenting in the 34th week of gestation, the risk of neonatal respiratory morbidity was 39.4% (95% CI, 30.8-47.9%) without steroids and 32.0% (95% CI, 24.6-39.4%) with steroids. In contrast, for patients presenting in the 36th week and planning vaginal delivery, the risk of neonatal respiratory morbidity was 6.9% (95% CI, 5.2-8.6%) without steroids and 5.6% (95% CI, 4.2-7.0%) with steroids.
The absolute risk difference of neonatal respiratory morbidity between those exposed and those unexposed to late preterm antenatal steroids varies considerably by gestational age at presentation and planned mode of delivery. Because only communicating the relative risk reduction of antenatal steroids for respiratory morbidity may lead to an inaccurate perception of benefit, more patient-specific estimates of risk expected with and without treatment may inform shared decision making.
根据计划分娩方式和就诊时的胎龄,评估晚期早产儿产前皮质类固醇对呼吸发病率亚组患者的影响。
这是一项多中心试验——ALPS(Antenatal Late Preterm Steroid,产前晚期早产儿皮质类固醇)试验的二次分析,该试验是在 Eunice Kennedy Shriver 国立儿童健康与人类发育机构的母胎医学单位网络内进行的,纳入了单胎妊娠且无既往糖尿病史的个体,这些个体存在晚期早产儿分娩(34-36 孕周)的高危因素。我们拟合二项式回归模型,以估计就诊时胎龄和计划分娩方式的情况下,有无皮质类固醇治疗时呼吸发病率的风险。我们假设皮质类固醇对对数几率的影响是同质的,这与 ALPS 试验中的报告一致。主要结局是 ALPS 试验中定义的新生儿呼吸发病率。
该分析包括 2825 例有晚期早产儿分娩风险的患者。呼吸发病率的风险因计划分娩方式(调整后的风险比[RR]1.90,95%置信区间,1.55-2.33,剖宫产 vs 阴道分娩)和就诊时的孕周而显著不同(调整后的 RR 0.56,95%置信区间,0.50-0.63)。对于计划行剖宫产且就诊于 34 孕周的患者,如果不使用皮质类固醇,新生儿呼吸发病率的风险为 39.4%(95%置信区间,30.8-47.9%),如果使用皮质类固醇,则为 32.0%(95%置信区间,24.6-39.4%)。相比之下,对于就诊于 36 孕周且计划行阴道分娩的患者,如果不使用皮质类固醇,新生儿呼吸发病率的风险为 6.9%(95%置信区间,5.2-8.6%),如果使用皮质类固醇,则为 5.6%(95%置信区间,4.2-7.0%)。
暴露于晚期早产儿产前皮质类固醇与未暴露于皮质类固醇的新生儿呼吸发病率的绝对风险差异在就诊时的胎龄和计划分娩方式方面有很大差异。由于仅沟通产前皮质类固醇治疗对呼吸发病率的相对风险降低可能导致对益处的不准确感知,因此更具体的患者在治疗和不治疗情况下的预期风险估计可能有助于共同决策。