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An investigation of the relationship between the prescribing of medicines to pregnant women and birth outcomes.

Safe People

Organisation name

Queen's University Belfast

Organisation sector

Academic Institute

Applicant name(s)

Prof Ciaran O'Neill

Funders/ Sponsors

Department for the Economy QUB PhD studentship.

DEA accredited researcher?

Yes

Safe Projects

Project ID

E099

Lay summary

It has been estimated that as little as 5%, or 1 in 20, prescription medicines have been adequately monitored, tested, and labelled with safety information for use in pregnant and breastfeeding women. The main reason for this is that pregnant women are typically not included in clinical trials. We hope to do a research study using anonymised data as part of a university PhD project to look at use of 4 different types of medicines during pregnancy. These include medicines prescribed to treat anxiety (anxiolytics), and other mental health conditions such as depression or schizophrenia (antidepressants and antipsychotics), and infections (antibiotics). The main aim of this study is to investigate trends or patterns in how these medicines are used during pregnancy in Northern Ireland, and to also add knowledge about the potential impact they might have on the health of babies. In our study, we would like to look at patterns of how these medicines have been prescribed in pregnant women in Northern Ireland from approximately 2010 onwards, and whether these are linked to different factors such as the mother’s age, and lifestyle factors (such as smoking and alcohol use). We also hope to explore the relationship between prescribing of these medicines and certain diagnoses or outcomes in babies at birth (such as preterm/early births and low birth weight), admissions into neonatal intensive care after birth, and the number of hospital admissions in infants under the age of 2 years. To do this, we plan to use anonymised data from: 1) a maternity healthcare database (to get information relating to the pregnancy and certain diagnoses in babies), 2) prescribing data (to get information on prescription medicines that have been issued to the mothers), and 3) hospital admission data (to get the information relating to admission of babies to neonatal intensive care, and the number of hospital admissions in infants under the age of 2 years). All data will be anonymised, that is, researchers will not have access to information such as names or addresses, and the data will be analysed in a secure computer setting.

Public benefit statement

It has the potential to provide real world evidence on trends of prescribing of the medicines of interest, factors/covariates associated with their prescribing, and also risk estimates of associated birth/infant outcomes. If elevated risks are identified the study could be useful to add to the body of evidence relating to safety of medicines in pregnancy and potentially in the development of health education messages to manage that risk – for example, the importance of discussion of prescribers when considering pregnancy.

Other approval committees

Latest approval date

23/09/2024

Safe Data

Dataset(s) name

NIMATS (Northern Ireland Maternity System)

Enhanced Prescribing Dataset (EPD)

National Health Application and Infrastructure Services (NHAIS)

Safe Setting

Access type

TRE

Safe Outputs

Link to research outputs