| IMI ConcePTION Project |
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The EUROmediCAT Network partipates in the ConcePTION Project: Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation.
This project funded by the EU Innovative Medicines Initiative started in April 2019 to run for 5 years. EUROmediCAT is conducting Workpackage 1: Secondary use of existing data sources for studies of medication safety in pregnancy. This involves the use of registries and healthcare databases.
Five Demonstration Projects will be carried out, in the therapeutic areas of neuropathic pain, depression, multiple sclerosis, SLE, migraine and breast cancer. These projects have been chosen to cover a wide range of methodological issues, as well as meeting important evidence gaps.
Workpackage 1 is led by Helen Dolk. The Demonstration Projects are led by Christine Damase-Michel, Maria Loane, Joan Morris, Hedvig Nordeng and Maarit Leinonen. Other EUROmediCAT partners include Sue Jordan, Anna Pierini, Amanda Neville, Clara Cavero, Jorieke Kammen-Bergman. Many EUROmediCAT members are also participating, as Data Access Providers, to the construction of an informatics platform in Workpackage 7. For more information, see www.imi-conception.eu
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Glossary of Terms used in Pharmacolvigilance and Pharmacoepidemiology
A plethora of terms (sometimes confusing) are deployed in pharmacolvigilance and medicines management research and practice. This glossary aims to clarify terminology, and its provenance, as a component of the quality initiative in Conception and other studies. Whilst some definitions are taken from official sources, others, absent in these sources, are drawn from contemporary literature with references. We hope readers will find this useful.
Working Definitions & Glossary for WP1 of IMI Conception 
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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
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| Association between maternal use of antibiotics in the first trimester and risk of congenital anomaly |
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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])
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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.
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Hierachical models in the analysis of emdication use during pregnancy and congenital anomalies
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Alana Cavadino, PhD Student, Queen Mary University of London ([email protected])
Prof Joan Morris, Queen Mary University of London ([email protected])
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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.
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| A European case-malformed control study of Gastroschisis with special emphasis on medication exposure |
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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
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| 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 |
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Me-D-Links: Maternal and infant health and educational outcomes following metformin exposure in pregnancy – analysis of linked administrative data
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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
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| 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. |
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| Exposure to sex hormones in early pregnancy and risk of congenital anomaly |
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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
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| 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. |
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| Beta-blocker use in pregnancy and risk of specific congenital anomalies: a European case-malformed control study |
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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
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| 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. |
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