Best Use of Medicines in Pregnancy Safety Monitoring System
Research type
Research Study
Full title
Using the BUMPS (Best Use of Medicines in Pregnancy) pregnancy registry to monitor the safety of maternal medication use in pregnancy.
IRAS ID
334373
Contact name
Kenneth Hodson
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
14 years, 11 months, 31 days
Research summary
It is difficult to study the safety of medicines in pregnancy using standard drug safety research methods. In many studies, important data about the mother’s lifestyle and/or over-the-counter medication use are missing, information about the time the pregnancy occurred and even pregnancy outcomes can be inaccurate, and long-term childhood health and development outcomes are rarely available. Collecting information directly from pregnant women may provide a solution to some of these problems. In this study pregnant women will be invited to report information about their pregnancy, any medicines they used, the outcomes of their pregnancy, and their infants’ development. This information will be used to study how useful collecting data from pregnant women is for helping to establish the safety of medicines when used in pregnancy, and the data collected will be used to monitor the safety of maternal medication use in pregnancy. This will help to improve understanding of the benefits and risks associated with medicines use in pregnancy.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0025
Date of REC Opinion
30 Jan 2024
REC opinion
Favourable Opinion