| Methods |
Randomised trial. |
| Participants |
150 women < 32 weeks at imminent risk of delivery (active labour not responding to tocolysis, preterm prelabour rupture of the membranes, or maternal complication).
Consent obtained only from treatment group. |
| Interventions |
390 mg intravenously phenobarbital if in active labour, if not in labour 720 mg in 3 oral doses every 4 hours, then 60 mg orally every 6 hours (n = 75). Control group given no treatment (n = 75). |
| Outcomes |
Primary outcome: IVH.
Other: respiratory distress syndrome, Apgar scores, need for resuscitation. |
| Notes |
Antenatal steroids given "whenever possible".
Phenobarbital used postnatally to all babies (2.5 mg/kg every 12 hours for 4 days). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Randomly assigned by the last digit of the hospital chart number. |
| Allocation concealment? |
High risk |
|
| Blinding?
All outcomes |
High risk |
No placebo was used however the assessment of the primary outcome was blinded. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
No exclusions specified. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
High risk |
55% (41/75) of patients in the phenobarbital group were given corticosteroids compared with 37% (28/75) in the control group. |
