The WHO ACTION-II (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 late preterm period in hospitals in low-resource countries to improve newborn outcomes

WHO ACTION-II 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 late preterm period in hospitals in low-resource countries to improve newborn outcomes

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001494325

Acronym

The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) II Trial

Enrollment

Registered

2017-10-23

Start date

2017-12-26

Completion date

2019-09-30

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this trial is to determine whether antenatal corticosteroids are safe and efficacious for women and newborns in resource-limited settings, when given to women with a live fetus/es at risk of imminent preterm birth from 34 weeks 0 days to 36 weeks 0 days gestation in facilities for the prevention of neonatal deaths.

Interventions

Antenatal corticosteroids (Dexamethasone IM) The drug regimen for this trial is aligned with the WHO recommendations on use of antenatal corticosteroids. The intervention regimen will be: - A single course of 6mg dexamethasone by intramuscular injection, administered every 12 hours, to a total of four (4) doses (time points 0 hours, 12 hours, 24 hours and 36 hours) - If the full regimen is completed, the woman would have received a total of 24mg in divided doses No repeat course(s) will be use

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Healthy volunteers

Yes

Inclusion criteria

- Birth planned or expected within 48 hours - Gestational age from 34 weeks 0 days to 36 weeks 0 days - 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)

Exclusion criteria

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

Outcome results