Very little is often known about the effects of medications taken during pregnancy, as this research is difficult to carry out. Women with a chronic inflammatory disease often need to take some form of medication to manage pain and other symptoms. This study aims to get a better understanding of how often medications are prescribed to women with the most common chronic inflammatory conditions (rheumatoid arthritis, psoriasis, psoriatic arthritis, inflammatory bowel disease, enteropathic arthritis, and spondyloarthritis) in the period before, during and after pregnancy. The study will also look at patient characteristics, pregnancy outcomes (live births, stillbirths and pregnancy losses) and congenital malformations in the offspring.
The study will use anonymised data from general practice records, from which no patients can be identified. For women with one of the diseases of interest, it will look at the prescriptions they receive in the period surrounding and during pregnancy and note any changes in prescribing. It will also compare patient characteristics and pregnancy outcomes in the pregnant women with one of these diseases to a group of pregnant women without these diseases.
This study has the benefit of being specific to prescribing and disease management in the UK and will be one of the largest studies conducted so far. It will provide further information for women and their healthcare providers to help in understanding how best to manage these diseases in order to have the best chance of healthy pregnancy outcomes.
Women with chronic inflammatory diseases often need to take some form of medication to manage pain and other symptoms. This study aims to better understand how often medications are prescribed to women with the most common chronic inflammatory conditions (rheumatoid arthritis, psoriasis, psoriatic arthritis, inflammatory bowel disease, enteropathic arthritis and spondyloarthritis) in the period before, during and after pregnancy. The study will also look at patient characteristics, pregnancy outcomes (including, live births, stillbirths and pregnancy losses) and major congenital malformations (MCMs) in the offspring.
The study will use anonymised data from CPRD GOLD. The study period will run from 01-Jan-2000 until 30-Jun-2021. Women with ≥1 pregnancy and a diagnosis of one of the inflammatory conditions of interest before or during pregnancy will be eligible for inclusion. The percentage of pregnancies where the woman received a prescription for conventional synthetic Disease Modifying Anti-Rheumatic Drugs, corticosteroids and Non-Steroidal Anti-inflammatory Drugs will be calculated for 3-month time periods in the year before and after pregnancy and for each pregnancy trimester. Each pregnancy will then be matched to pregnancies in women without a chronic inflammatory disease (1:6 ratio), based on maternal age and calendar year at pregnancy start. Patient characteristics and the frequencies of different types of pregnancy outcomes and MCMs will be calculated for the two groups. Absolute risks of each outcome will be reported with 95% confidence intervals.
For each adverse pregnancy outcome, conditional logistic regression will be used to determine the likelihood of an adverse pregnancy outcome in women with each of the chronic inflammatory diseases compared to women in the matched cohort, adjusting for confounding factors where appropriate. The study results will provide further information for women and healthcare providers to help understand how best to manage these diseases to have the best chance of healthy pregnancy outcomes.
Medication exposures (specifically conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs), corticosteroids and Non-Steroidal Anti-inflammatory Drugs (NSAIDs)); pregnancy outcomes (including live births, stillbirths, spontaneous pregnancy loss and induced terminations); major congenital malformations.
Rachel Charlton - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Julia Snowball - Collaborator - University of Bath
Neil McHugh - Collaborator - University of Bath
William Tillett - Collaborator - University of Bath