Antenatal Corticosteroids Trial in Preterm Births to Increase Neonatal Survival in Developing Countries

ACT, funded by the NICHD, studied the feasibility, effectiveness and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids (ACS) at all levels of health care in low- and middle-income countries. Investigators conducted a two-arm parallel cluster randomized trial of women enrolled in the Global Network Maternal Newborn Health Registry. Intervention clusters received health-provider training, posters, pregnancy disc, and uterine height tape to facilitate identification of women at risk of preterm birth, and ACS kits. All health providers in intervention clusters were trained to identify women presenting before 36 weeks’ gestation with signs of labor, PPROM, pre-eclampsia/eclampsia, or obstetric hemorrhage as at high risk of preterm birth and potential candidates for ACS. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birth weight (a proxy for preterm birth).本研究由美国国立儿童健康与人类发育研究所（National Institute of Child Health and Human Development, NICHD）资助，旨在评估一项多维度干预措施的可行性、有效性与安全性，该措施旨在提升中低收入国家各级医疗保健机构产前皮质类固醇（antenatal corticosteroids, ACS）的使用比例。研究人员针对纳入全球孕产妇新生儿健康登记系统（Global Network Maternal Newborn Health Registry）的女性受试者开展了双臂平行整群随机对照试验。干预组整群将获得医疗人员专项培训、宣传海报、孕周盘及子宫高度测量尺，用于辅助识别早产高风险女性，并配备ACS给药包。所有干预组整群内的医疗人员均需接受相关培训，能够识别妊娠36周前出现临产征象、胎膜早破（preterm premature rupture of membranes, PPROM）、子痫前期/子痫或产科出血的早产高风险人群，将其列为ACS的潜在适用对象。本研究的主要结局指标为出生体重低于第5百分位的婴儿的28天新生儿死亡率，该指标可作为早产的替代评价指标。