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Medication Safety in Pregnancy

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Research Projects
(For complete research projects see Publications)


MumPredict ( 2020 - 2024

MumPredict is a UK MRC funded study of pregnancy for women with two or more long term health conditions, running from 2020-2024. EUROmediCAT is collaborating in this study in Workpackage 4, devoted to polypharmacy in pregnancy.


EUROmediCAT researchers are collaborating in the analysis of UK electronic health data on polypharmacy, and the EUROmediCAT central database will also be analysed in relation to the frequency and combinations of drugs used, and the association of specific congenital anomalies with specific polypharmacy combinations.


COVICAT 2022 - 2024

COVICAT is a study of Covid in pregnancy in Ireland and Europe, and will investigate whether there is any correlation between the infection or vaccination rate for Covid-19, and the rate of specific congenital anomalies in the population.


The study is funded under the Higher Education Authority of Ireland North-South collaborative funding programme, from 2022-2024. The study will involve EUROmediCAT registries, as well as EUROCAT registries which are not part of EUROmediCAT.

Eurocaarv 2023 - ongoing

More than 1 million of pregnant women have received an antiretroviral drug (ARV) worldwide. Despite the benefit effects of ARV for the mother’s health and for preventing mother-to-child transmission, the prenatal exposure to these medications still raises concerns on the potential effects of some of them on the foetus


The Eurocaarv project aims to evaluate the risk of congenital anomalies after exposure to antiretroviral drugs, using the data of 14 registries participating to the EUROmediCAT central database, from 1995.  


An exhaustive case series and case-malformed control study are ongoing, to investigate antiretroviral exposure during pregnancy and congenital anomalies.

Medikeye 2021 - ongoing

Eye anomalies are among the most common causes of visual impairment in children in developed countries. The participation of medications in their genesis is little described in humans except for few “old” medications known for their polymalformative teratogenicity.


The Medikeye project describes Congenital ocular anomalies across European countries, and investigates the potential association between medication prenatal exposure and the occurrence of these anomalies. It involves18 congenital anomaly registries from 13 European countries covering more than 11 million births across Europe.


First results on the prevalence of the different types of congenital eye anomalies in Europe have been released during the last meeting of the International Society of PharmacoEpidemiology in Copenhagen and the investigation on the potential role of medications is on progress.

Dubucs C et al, The Medikeye project, the first European study on in utero medicine exposure and congenital anomalies of eyes. ICPE 2022 Copenhagen


Prescription medicines in pregnancy and Known Risks: An Overview

Adverse perinatal outcomes remain an important public health issue. Identification of inter-generational developmental adverse drug reactions (ADRs) poses complex questions, including those surrounding medicines exposures and co-exposures. This document lists medicines and other exposures that may present a risk to the foetus, and should, ideally, be accounted for when investigating possible harms of prescription medicines. Strategies for handling these risks in epidemiological analyses are suggested.


Prescription Medines in Pregnancy & Known Risks - An Overview pdf icon small

Association between maternal use of antibiotics in the first trimester and risk of congenital anomaly

Mr Leke Z Aminkeng, PhD Student, Ulster University 

Dr Karen Casson, Ulster University

Prof Helen Dolk, Ulster University
Dr Maria Loane, Ulster University ([email protected]

Considering the high prevalence and importance of use of antibiotics during pregnancy and the need for adequate data to inform the decision of clinicians and pregnant women on the risk of teratogenicity, more powerful studies are needed on the risk of congenital anomaly associated with maternal use of antibiotics.  This project is using data from the EUROmediCAT central database to test signals in the literature regarding the association between specific antibiotics and specific congenital anomalies.


The study includes data from 18 registries in 14 countries covering a population of 8.5 million births, 1995-2012.


Hierachical models in the analysis of emdication use during pregnancy and congenital anomalies

Alana Cavadino, PhD Student, Queen Mary University of London ([email protected])

Prof Joan Morris, Queen Mary University of London ([email protected])

A signal detection method has been developed using the EUROmediCAT database to routinely identify potential teratogenic medications taken during the first trimester of pregnancy.  This method uses a 1-sided Fisher's exact test to compare the odds of exposure of a specific congenital anomaly and drug to the odds of exposure to the same drug in the remainder of the dataset (ie. all other drug-exposed anomalies).  Each medication and each anomaly is examined separately, using ATC-5 or ATC-4 codes for drug exposures and EUROCAT subgroup codes for anomalies.


This project aims to refine this methodology by combining information from similar medications (for example antiepileptic medications) or similar anomalies (for example spina bifida and anencephaly) when determing statistical signficance.  This pooling of information may increase the power to detect associations, particularly for newer drugs with fewer exposures.  Information will be combined using hierarchical models that specify that a set of drugs, for example, all belong to the same class of drugs and are, therefore, expected to have similar teratogenic properties.

A European case-malformed control study of Gastroschisis with special emphasis on medication exposure

Dr Joanne Given, Research Associate, Ulster University ([email protected])

Prof Helen Dolk, Ulster University

Dr Ester Garne, Hospital Lillebaelt, Denmark

Dr Maria Loane, Ulster University 

This project aims to examine risk factors for gastroschisis in the EUROmediCAT database, with particular emphasis on maternal disease and first trimester drug exposure. This will be done through a case-malformed control design using data from 18 EUROmediCAT registries from 1995-2012 

Me-D-Links: Maternal and infant health and educational outcomes following metformin exposure in pregnancy – analysis of linked administrative data

Dr Joanne Given, Research Associate, Ulster University ([email protected])

Prof Helen Dolk, Ulster University

Dr Ester Garne, Hospital Lillebaelt, Denmark

Ms Ruth Greenlees, Ulster University

Dr Maria Loane, Ulster University 

This study aims to investigate if 1st trimester metformin exposure increases the risk of all or specific congenital anomalies using an exploratory case-malformed control design. Metformin if used for gestational diabetes or pre-gestational diabetes may lead to lowering of risk of CA due to improved glycaemic control, or to raised risk of specific CA due to teratogenic action, or both. This analysis is not designed to look for a lowering of risk of malformations associated with diabetes, but only for an independent teratogenic action. 
Exposure to sex hormones in early pregnancy and risk of congenital anomaly

Dr Joanne Given, Research Associate, Ulster University ([email protected])
Prof Helen Dolk, Ulster University
Prof Stephen Hillier, University of Edinburgh
Dr Ester Garne, Lillebaelt Hospital, Denmark
Ms Ruth Greenlees, Ulster University
Dr Maria Loane, Ulster University
Prof Kay Marshall, Manchester University 

In the EUROmediCAT signal detection study, signals for risk of specific congenital anomalies associated with selected sex hormone exposures were found (Abstract).  There is a large and conflicting body of literature relating to the teratogenicity of the sex hormones with many types of sex hormones inappropriately grouped together, different congenital anomalies (CA) grouped together, and various sources of potential bias.  Interpretation of the evidence is complicated further by the potential for confounding by indication (eg. infertility problems associated with hypospadias risk), and the potential for progesterone compounds to maintain pregnancy and perhaps increase survival of CA-affected foetuses.  This study aims to explore the risk of specific congenital anomalies following exposure to sex hormones in early pregnancy. This will be done through a case-malformed control design using data from 18 EUROmediCAT registries from 1995-2013. 
Beta-blocker use in pregnancy and risk of specific congenital anomalies: a European case-malformed control study 

Dr Jorieke van Kammen-Bergman, Eurocat Northern Netherlands, University Medical Center Groningen ([email protected])
Ms Renee Lutke, Eurocat Northern Netherlands, University Medical Center Groningen

Dr Marian Bakker, Eurocat Northern Netherlands, University Medical Center Groningen 

The prevalence of hypertension is increasing, also in pregnant women.  Especially obese and older mothers are at increased risk.  The aim of this study is to investigate whether first trimester use of beta-blockers increases the risk of specific congenital anomalies in offspring by using data from EUROmediCAT.  We will perform a population-based case-malformed control study using data from 17 EUROmediCAT registries.  We will test associations previously reported in literature (signals) and perform an exploratory analysis to identify new signals.