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Are nicotine replacement therapy and varenicline safe and effective for women trying to quit smoking during pregnancy?

image - NRT Varenicline Pregnancy
Drug Type:
Project Members: 
image - Alys Havard Staff Photo 1 2015.05.04
Senior Research Fellow
Ph +61 2 9385 0646
Project Main Description: 

 

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

Rationale: 

 

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.

 

Aims: 

 

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

 

Drug Type: 
Project Status: 
Current