Methods |
Country: Australia
Setting: maternity hospital
CT: allocation by month of delivery |
Participants |
184 parents of newborn babies whose mothers smoked during pregnancy |
Interventions |
Intervention: Mothers in the maternity hospital were given an information kit about the effects of ETS on children and ways to quit smoking, along with a letter from the director of the Neonatal Intensive Care Unit urging parents to avoid exposing children to ETS. The kit was given to women by a research worker, who explained the material and answered questions. Women were telephoned at 1 month and were asked about their progress and use of the kit, and were given further information if required.
Control and follow‐up only: did not receive the above intervention |
Outcomes |
At 3 months:
• Infant urine cotinine levels
• Maternal quitting, maternal cotinine |
Type of intervention |
Well‐child (peripartum) |
Notes |
Retention: 157/184 (85%) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
Non‐randomised; group assignment by month of admission |
Allocation concealment (selection bias) |
High risk |
See above. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Similar and high rates of follow‐up in both groups (54/61 intervention, 57/62 control) |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Biological validation used |