Trial Period: MNHR fetal/infant data in Antenatal Corticosteroids Trial in Preterm Births to Increase Neonatal Survival in Developing Countries

Fetal/infant characteristics collected by the Maternal Newborn Health Registry during the ACT Trial
Study Description
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). In the 50 intervention clusters 46,172 pregnant women, 45,369 live births(LB) and 1,266 stillbirths(SB) and in the 50 control clusters 51,523 pregnant women, 50,743 LB and 1,264 SB were enrolled, completed follow-up and are included in this data release.

ACT试验期间由孕产妇新生儿健康登记系统（Maternal Newborn Health Registry）收集的胎儿/婴儿特征数据
研究描述
本试验（ACT）由美国国立儿童健康与人类发展研究所（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对产前糖皮质激素（antenatal corticosteroids, ACS）的使用比例。研究人员针对纳入全球网络孕产妇新生儿健康登记系统（Global Network Maternal Newborn Health Registry）的妊娠女性开展了一项双臂平行整群随机试验。干预组整群接受了医疗人员培训、宣传海报、妊娠孕周盘以及子宫高度测量尺，用于辅助识别早产风险人群，并配备了ACS试剂盒。干预组所有医疗人员均接受标准化培训，可识别妊娠36周前出现临产征象、早产胎膜早破（preterm premature rupture of membranes, PPROM）、子痫前期/子痫或产科出血的妊娠女性，将其判定为早产高风险人群及ACS潜在适用对象。主要结局为出生体重低于第5百分位数的婴儿的28天新生儿死亡率（该指标可作为早产的替代评估指标）。本数据发布纳入的研究对象包括：50个干预整群中的46172名孕妇、45369例活产（live births, LB）以及1266例死产（stillbirths, SB）；50个对照整群中的51523名孕妇、50743例活产以及1264例死产，所有研究对象均完成随访并被纳入本次数据发布。