| Methods |
Country: Denmark
Recruitment: volunteers, antenatal clinic |
| Participants |
250 pregnant women who continued to smoke after 1st trimester
Average age 28, average cpd 14; 43% primiparous |
| Interventions |
1. Nicotine patch (15 mg/16 h, tapering to 10 mg, 11 weeks total)
2. Placebo patch
Level of support: high. 4 x 15‐ to 20‐min sessions of midwife counselling at 0, 4,11 weeks from enrolment, and 4 weeks before expected delivery |
| Outcomes |
Abstinence at 4 weeks prior to delivery and at 1 year post‐partum (telephone interview). (Rates at 3 months post‐partum also reported)
Validation: Cotinine < 26 ng/ml at 4 weeks pre‐delivery visit only |
| Notes |
First long‐term study of nicotine patch in pregnancy. Compliance with patch use was low. Only 17% of active and 8% of placebo used all patches. Data used in Analysis 5.1 from 2012 is abstinence at 4th prenatal visit rather than continuous abstinence from 2nd to 4th prenatal visit, for consistency with Coleman 2015. The effect estimate is not altered
Study was funded by the Danish Cancer Society and the Department of Health, and supported by Pharmacia & Upjohn |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomization. Quote: "Pharmacia & Upjohn ... generated the randomization list, supplied the patches with randomization numbers, and kept the code between patch number and the specific treatment until data collection was finished". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Women ... were assigned consecutive numbers on the randomization list" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote: "Treatment status was not known by the women or the midwife throughout the study" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data reported, and included as smokers. Analyses were ITT |
