| Methods |
Randomised clinical trial. |
| Participants |
160 women in preterm labour at < 35 weeks with or without ruptured membranes. |
| Interventions |
10 mg/kg (maximum of 100 mg) phenobarbital intravenously over 30 minutes, then 100 mg daily until delivery or 34 weeks (n = 84). The control group received no treatment (n = 76). |
| Outcomes |
Primary outcome: intracranial haemorrhage.
Outcomes of follow up at 24‐36 months: physical growth, neurologic and developmental outcome. |
| Notes |
Sample size calculation done. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Randomly assigned using a card deck. |
| Allocation concealment? |
Unclear risk |
Not reported. |
| Blinding?
All outcomes |
High risk |
No placebo was used however the assessment of the primary outcome was blinded. |
| Incomplete outcome data addressed?
All outcomes |
High risk |
34 of 84 (40%) women randomised into the phenobarbital group were excluded due to cessation of labour, continuation of pregnancy beyond 34 weeks and incomplete infusion of the drug before delivery. However, only 16 of 76 (21%) women randomised to the control group were excluded for those reasons. 21/62 (34%) infants in the phenobarbital group and 19/74 (26%) infants in the control group were excluded from the follow up at 36 months (in total 40/136 (29%) infants at randomisation were excluded). Reasons for exclusion included death postdischarge, failure to keep at least 4 follow up appointments, diagnosis of trisomy and failure to keep the 36 month visit. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
Low risk |
|
