AIMS: To test the efficacy of 'MiQuit', a tailored, self-help, text message stop smoking programme for pregnancy, as an adjunct to usual care (UC) for smoking cessation in pregnancy.

DESIGN: Multicentre, open, two-arm, parallel-group, superiority randomised controlled trial (RCT) and a trial sequential analysis (TSA) meta-analysis combining trial findings with two previous ones.

SETTING: Twenty-four English hospital antenatal clinics. A total of 1002 pregnant women who were ≥16 years old, were ≤25 weeks gestation and smoked ≥1 daily cigarette and accepted information on cessation with no requirement to set quit dates.

INTERVENTIONS: UC or UC plus 'MiQuit': 12 weeks of tailored, smoking cessation text messages focussed on inducing and aiding cessation. Measurements were primary outcome: biochemically validated cessation between 4 weeks after randomisation and late pregnancy. Secondary outcomes were shorter and non-validated abstinence periods, pregnancy outcomes and incremental cost-effectiveness ratios.

FINDINGS: RCT: cessation was 5.19% in MiQuit and UC groups; other abstinence findings were similar, with higher point estimates. Primary outcome ascertainment was 61.7% (309) and 67.3% (337) in MiQuit and UC groups with 71.1% (54/76) and 69.5% (41/59) abstinence validation rates, respectively. Pregnancy outcomes were similar and the incremental cost per quality-adjusted life year was -£1118. More MiQuit group women reported making at least one quit attempt for making an attempt, 1.50. TSA meta-analysis: this found no significant difference in prolonged abstinence between MiQuit and UC.

CONCLUSIONS: Irrespective of whether they want to try quitting, when offered a tailored, self-help, text message stop smoking programme for pregnancy (MiQuit) as an adjunct to usual care, pregnant women are not more likely to stop smoking until childbirth but they report more attempts at stopping smoking.