| Methods |
Randomised controlled trial. |
| Participants |
100 women with a singleton pregnancy at 28‐32 weeks' gestation at risk of preterm birth.
Excluded if taking 'hemostasia' drugs or if they have an autoimmune disease. |
| Interventions |
Those in the phenobarbital group given phenobarbital 10 ug/kg diluted in 100 ul of 5% dextrose solution via a 30‐minute infusion (n = 42). Those in the control group given "diluted distilled water dosaged at the same time" (n = 46). Both given at least 4 hours and more than 24 hours before the caesarean section. |
| Outcomes |
Primary outcome: PVH.
Secondary outcome: neonatal mortality and morbidity. |
| Notes |
Antenatal steroids only given to 5/88 (6%) women.
Reasons for exclusions: stillbirth (1), major congenital malformation (1), no head ultrasound (2), moved hospital (1), technical difficulties in blood sampling (7).
No sample size calculation given. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Not reported. |
| Allocation concealment? |
Unclear risk |
Not reported. |
| Blinding?
All outcomes |
Low risk |
A placebo was used and the assessment of the primary outcome was blinded. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
12% (12/100) were lost to follow up. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
Low risk |
|
