A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries to improve newborn outcomes - Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns (ACTION-I TRIAL)

World Health Organization0 个研究点目标入组 579 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Trial participants will be pregnant women coming to the hospital for delivery. Participants will be eligible for the trial if
•1 Birth planned or expected within 48 hours
•2 Gestational age from 26 weeks 0 days to 33 weeks 6 days
•3 Women with singleton or multiple pregnancies, where the fetus(es) is(are) alive
•4 Women with no clinical signs of severe infection (as per clinical assessment)
•5 Women willing and able to provide consent
•Women with the following conditions are eligible. Any comorbid conditions will be managed according to local guidelines,and in line with WHO recommendations:
•6 Women with a history of previous preterm birth
•7 Women with hypertensive disorders
•8 Women with a growth impaired fetus
•9 Women with pre-gestational or gestational diabetes
•10 Women with HIV/AIDs

•1 Intrauterine fetal death
•2 Major or lethal congenital fetal anomaly identified
•3 Clinical suspicion or evidence of clinical chorioamnionitis, as per obstetric care physician assessment
•4 Clinical suspicion or evidence of severe infection, as per obstetric care physician assessment
•5 No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible
•6 Any concurrent or recent (within the past 2 weeks) systemic corticosteroid use during the current pregnancy (outside of trial)
•7 Unwilling or unable to provide consent
•Currently a participant in another clinical trial related to maternal and neonatal health
•8 Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated

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