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Project deliverable . 2021
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Executive summary of CONSIGN interim deliverables

Authors: Sturkenboom, Miriam;

Executive summary of CONSIGN interim deliverables

Abstract

To generate knowledge about the use and effects of medicines use in COVID-19 affected pregnancies a collaboration was established across many countries and several ongoing pregnancy networks: IMI-ConcePTION, EU PE & PV, COVI-PREG and INOSS. This deliverable is an executive summary about progress of the CONISGn project that is funded by EMA to monitor medicines use and effects during COVID-19 exposed pregnancies, until July 2021 and comprises: Data on medication utilization in COVID-19 affected pregnancies from COVI-PREG (n=1,946), INOSS (n=927) and 5 electronic health care data sources in four European countries (capturing 2,022 COVID-19 pregnancies). Data from COVI-PREG and INOSS capture in hospital/clinic prescribing. Data from electronic health care data capture outpatient dispensings of prescriptions in primary and secondary (outpatient) care. Interim analysis of INOSS data on maternal, obstetric and neonatal outcome in COVID-19 diagnosed pregnant women.This analysis is prepared for publication Final analysis of COVI-PREG data on maternal, obstetric and neonatal outcomes in COVID-19 diagnosed pregnant women and the association with medicines use. This analysis is prepared for publication

The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network (led by the University Utrecht). Scientific work for this project was coordinated by the University Medical Center Utrecht. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/23/PE. This document expresses the opinion of the authors of the paper, and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

Keywords

COVID-19, medicines, pregnancy

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