| Methods |
Setting: Prenatal care services, USA
Recruitment: Pregnant women in a managed care plan or referred by a care provider, not selected by motivation |
| Participants |
442 pregnant women smoking at least 1 cig in previous 7 days; av. age 29, av. cigs/day 21 prior to pregnancy, 10 at recruitment, 84% planned to quit |
| Interventions |
All participants received brief counselling at enrolment call and mailed a pregnancy‐tailored S‐H booklet
1. Proactive counselling, up to 90 mins during pregnancy and 15 mins postpartum, + targeted written materials
2. Usual care |
| Outcomes |
Abstinence 3 m postpartum (sustained at end of pregnancy and 3 m)
Validation: saliva cotinine ≤ 20 ng/mL |
| Notes |
Mean of 5 calls received, 4 in pregnancy, av. 68 mins in total |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "computer‐generated randomization list arranged in balanced blocks of 4 and stratified by referral source" |
| Allocation concealment (selection bias) |
Low risk |
Quote: "... the application revealed the next assignment only after the smoker had consented to participate in the study" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Biochemical validation; those who failed biochemical validation or did not provide a sample counted as smokers |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
21 miscarriages excluded. 33% Intervention, 28% Control lost to follow‐up, included as smokers |
