BACKGROUND:Tobacco smoking in pregnancy remains one of the few preventable factors associated with complications in pregnancy, low birthweight, preterm birth and has serious long-term health implications for women and babies. Smoking in pregnancy is decreasing in high-income countries and increasing in low- to middle-income countries and is strongly associated with poverty, low educational attainment, poor social support and psychological illness. OBJECTIVES:To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. SEARCH STRATEGY:We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2008), the Cochrane Tobacco Addiction Group's Trials Register (June 2008), EMBASE, PsycLIT, and CINAHL (all from January 2003 to June 2008). We contacted trial authors to locate additional unpublished data. SELECTION CRITERIA:Randomised controlled trials where smoking cessation during pregnancy was a primary aim of the intervention. DATA COLLECTION AND ANALYSIS:Trials were identified and data extracted by one person and checked by a second. Subgroup analysis was conducted to assess the effect of risk of trial bias, intensity of the intervention and main intervention strategy used. MAIN RESULTS:Seventy-two trials are included. Fifty-six randomised controlled trials (over 20,000 pregnant women) and nine cluster-randomised trials (over 5000 pregnant women) provided data on smoking cessation outcomes.There was a significant reduction in smoking in late pregnancy following interventions (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.93 to 0.96), an absolute difference of six in 100 women who stopped smoking during pregnancy. However, there is significant heterogeneity in the combined data (I(2) > 60%). In the trials with the lowest risk of bias, the interventions had less effect (RR 0.97, 95% CI 0.94 to 0.99), and lower heterogeneity (I(2) = 36%). Eight trials of smoking relapse prevention (over 1000 women) showed no statistically significant reduction in relapse.Smoking cessation interventions reduced low birthweight (RR 0.83, 95% CI 0.73 to 0.95) and preterm birth (RR 0.86, 95% CI 0.74 to 0.98), and there was a 53.91g (95% CI 10.44 g to 95.38 g) increase in mean birthweight. There were no statistically significant differences in neonatal intensive care unit admissions, very low birthweight, stillbirths, perinatal or neonatal mortality but these analyses had very limited power. AUTHORS' CONCLUSIONS:Smoking cessation interventions in pregnancy reduce the proportion of women who continue to smoke in late pregnancy, and reduce low birthweight and preterm birth. Smoking cessation interventions in pregnancy need to be implemented in all maternity care settings. Given the difficulty many pregnant women addicted to tobacco have quitting during pregnancy, population-based measures to reduce smoking and social inequalities should be supported.