The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial

Area of Science:

• Public Health
• Maternal and Child Health
• Health Economics

Background:

• Pregnancy cessation interventions are crucial, as 70% of Scottish women have children.
• Quitting smoking during pregnancy protects infants from miscarriage, low birth weight, and developmental issues.
• Limited evidence exists on the efficacy of financial incentives for pregnant smokers in the UK.

Purpose of the Study:

• To determine if financial incentives are acceptable, effective, and cost-effective for pregnant smokers in the UK.
• To assess the therapeutic efficacy of incentives for smoking cessation in pregnancy.
• To evaluate the feasibility and acceptability of implementing incentive programs.

Main Methods:

• A phase II exploratory randomized controlled trial involving 600 pregnant smokers.
• Comparison of standard care versus standard care plus financial voucher incentives.
• Primary outcome: self-reported smoking in late pregnancy verified by cotinine measurement; secondary: economic and qualitative assessments.

Main Results:

• The study will establish a workable design for a future phase III trial.
• It will provide a framework for assessing the costs and benefits of financial incentives.
• Exploratory data on efficacy, cost-effectiveness, and acceptability will be gathered.

Conclusions:

• This phase II trial is designed to inform a definitive phase III study on financial incentives for pregnant smokers.
• It will establish a framework for evaluating the economic and practical aspects of such interventions.
• Findings will guide future strategies to support smoking cessation in pregnancy.