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The Covid-19 infectiOn aNd medicineS In pregGNancy (CONSIGN) project implements various analyses to estimate the use of medicines and their effects in COVID-19 affected pregnancies to guide decision-making by EMA and its committees about vaccine indications, vaccination policies, and treatment options for COVID-19 disease and associated complications. CONSIGN builds on ongoing primary data collections in the EU initiated COVI-PREG and INOSS networks, and secondary use of data based on the IMI-funded ConcePTION tools and network (https://www.imi-conception.eu). The ultimate goal of this work is to create a global and sustainable infrastructure for prospective benefit-risk monitoring of treatments in pregnancy beyond those used in COVID-19 as part of the CONSIGN work. This report describes the data sources to be included in the CONSIGN-International meta-analysis that aims to assess medicine use and their effects on the management of COVID-19 in pregnancy. The key objectives of CONSIGN-International are to describe and estimate: Use of medicines to treat COVID-19 infection in pregnancy The impact of COVID-19 on pregnancy and neonatal outcomes In chapter 1, we describe the current status of the CONSIGN-International meta-analysis, including the rationale and a summary of the steps and procedures conducted so far. In chapter 2, we describe the data sources to be included in the CONSIGN-International meta-analysis. Paragraph 2.1 lists the data sources based on the secondary use of health care data, while paragraph 2.2 gives an overview of the data sources based on primary data collection from health clinics. In chapter 3, we elaborate on the proposed approaches and discuss the next steps of the CONSIGN-International meta-analysis., Deliverable by the EU PE & PV Research Network under a Framework contract following procurement procedure EMA/2018/28/PE (Lot 4). 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.