This project will measure the safety and effectiveness of quit smoking medicines, nicotine replacement therapy (NRT) and varenicline, during pregnancy. We will use routinely collected data from NSW, New Zealand and the Nordic countries to create a cohort of over 400,000 women who smoked during pregnancy and their children. Women who used NRT or varenicline during pregnancy will be compared to women who smoked but did not use these medicines in relation to quitting smoking and a range of adverse outcomes, including rare but severe events including congenital anomalies and stillbirth, and long-term child neurodevelopment.

Project Collaborators External

• Associate Professor Helga Zoega, Centre for Big Data Research in Health, UNSW Sydney
• Dr Danielle Tran, Centre for Big Data Research in Health, UNSW Sydney
• Dr Kari Furu, Norwegian Institute for Public Health
• Associate Professor Lianne Parkin, University of Otago
• Professor Sallie Pearson, Centre for Big Data Research in Health, UNSW Sydney
• Professor Nick Zwar, Bond University

Smoking during pregnancy is the largest preventable cause of adverse birth outcomes. The risk of these harms can be reduced substantially if mothers cease smoking in the first 20 weeks of pregnancy, but this is currently only achieved in 25% of cases. It is therefore vital to identify smoking cessation treatments that are effective and safe to use during pregnancy.

To determine the effectiveness and safety of NRT and varenicline during pregnancy

Design and Method

This is a cohort study based on linked administrative data from NSW, New Zealand and the Nordic countries

Progress/Update

The data for this project are currently being linked, with data delivery expected in the second half of 2022.

Benefits

The findings of this project will provide an evidence-base for clinical guidelines and consumer medicines information, thereby driving improvements in the care and outcomes of women smoking during pregnancy and their children