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Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial (RCT) and meta-analysis.

AIMS
To test 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
24 English hospital antenatal clinics.


PARTICIPANTS
1002 pregnant women who were ≥16 years old, were ≤ 25 weeks gestation, and smoked ≥ one 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
Primary outcome: biochemically-validated cessation between 4 weeks after randomisation and late pregnancy.


SECONDARY OUTCOMES
shorter and non-validated abstinence periods, pregnancy outcomes and incremental cost-effectiveness ratios.


FINDINGS
RCT: cessation was 5.19% (26/501) and 4.59% (23/501) in MiQuit and UC groups [adjusted odds ratio (adj OR) for quitting with MiQuit versus UC, 95% confidence interval (CI), 1.15 (0.65 to 2.04)]; 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 -£1,118 (95% CI -£4,806 to £1,911). More MiQuit group women reported making at least one quit attempt (adj OR (95% CI) for making an attempt, 1.50 (1.07 to 2.09).TSA Meta-analysis: This found no significant difference in prolonged abstinence between MiQuit and UC (pooled OR 1.49, adjusted 95% CI 0.62 to 3.60).


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.