None listed
Conditions
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 26 weeks 0 days to 33 weeks 6 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
- If a woman has not delivere
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 - If a woman has not delivered within 7 completed days after completion of the first course, is re-assessed as eligible (if the gestational age is still less than 34 weeks), and a subsequent clinical assessment demonstrates that birth is planned or expected in the next 48 hours, a second course according to the regimen described above will be administered. Hence, the use of a repeat course in eligible women shall be the same as the initial allocation (i.e. women initially randomized to dexamethasone will only receive dexamethasone as repeat course). No further repeat courses will be used (i.e. a maximum of two courses per participant). Adherence will be monitored through documenting number of injections administered to each participant.
Sponsors
World Health Organization
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 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)
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
None listed