Detection and evaluation of signals associated with exposure to individual and combination of medications in pregnancy: a signal detection study protocol.

ABSTRACT:

Introduction

Considering the high prevalence of polypharmacy in pregnant women and the knowledge gap in the risk-benefit safety profile of their often-complex treatment plan, more research is needed to optimise prescribing. In this study, we aim to detect adverse and protective effect signals of exposure to individual and pairwise combinations of medications during pregnancy.

Methods and analysis

Using a range of real-world data sources from the UK, we aim to conduct a pharmacovigilance study to assess the safety of medications prescribed during the preconception period (3 months prior to conception) and first trimester of pregnancy. Women aged between 15 and 49 years with a record of pregnancy within the Clinical Practice Research Datalink (CPRD) Pregnancy Register, the Wel

SUBMITTER: Subramanian A 

PROVIDER: S-EPMC10565241 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature