The WHO ACTION-I (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) Trial: 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
- Conditions
- preterm birthReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12617000476336
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 2852
Birth planned or expected within 48 hours
-Gestational age from 26 weeks 0 days to 33 weeks 6 days (see Figure 3)
-Women with singleton or multiple pregnancies, where the fetus(es) is(are) alive
-Women with no clinical signs of severe infection (as per clinical assessment)
-Women willing and able to provide consent (or if a minor, provides assent and guardian provides consent)
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
8. Currently a participant in another clinical trial related to maternal and neonatal health
9. Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method