| Methods |
Prospective randomised clinical trial. |
| Participants |
112 women in preterm labour or with prelabour preterm rupture of the membranes < 35 weeks.
Ineligible if known congenital abnormalities, maternal bleeding diathesis, severe pre‐eclampsia, or fetal distress needing delivery. |
| Interventions |
10 mg vitamin K intramuscularly repeated after 4 days if undelivered. If undelivered after a further 4 days oral vitamin K (20 mg) daily until end of 34th week (n = 56). The control group (n = 56) was given no treatment. |
| Outcomes |
IVH assessed by a radiologist blinded to treatment allocation on day 1, 3, and 14 after delivery.
Other neonatal morbidity, patent ductus arteriosus, apnoea.
Cord blood clotting profiles for a partial thromboplastin time, factor II, VII, X activity and antigen levels of factor II and X. |
| Notes |
Sample size. 50% reduction in PVH (from 40% to 20%) needed 46 babies in each group.
Patent ductus arteriosus reported as seen on echocardiogram, uncertain as to whether required treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
The cards were pre‐coded from a table of random numbers. |
| Allocation concealment? |
Unclear risk |
Women randomised to a treatment or control group by consecutively drawing cards. |
| Blinding?
All outcomes |
High risk |
No placebo used, but assessment of the primary outcome of IVH was blinded. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
22/112 (19.6%) women lost to follow up due to continuation of pregnancy beyond 34 weeks. |
| Free of selective reporting? |
Low risk |
No indication of selective reporting. |
| Free of other bias? |
Low risk |
No other bias evident. |
