Estimation of background incidence rates of coagulation disorders and the association with COVID-19 vaccines in pregnant population: a multi-database study from 3 European countries

Study identification

• EU PAS number:
  EUPAS1000000918
• Study ID:
  1000000918
• Official title and acronym:
  Estimation of background incidence rates of coagulation disorders and the association with COVID-19 vaccines in pregnant population: a multi-database study from 3 European countries
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Italy

  Netherlands

  Spain
• Study description:
  This study aims to estimate:; i)the background incidence rates of coagulation disorders—including thromboembolic and haemorrhagic events— during pregnancies and prior to vaccination with the EMA-approved COVID-19 vaccines ; ii)evaluate the association between the exposure to each of the EMA-approved COVID-19 vaccines (BioNTech/Pfizer, Moderna, AstraZeneca, J&J) and the coagulation disorders* in pregnant women through a self-controlled case series (SCCS) design; This study will be conducted using routinely collected healthcare data including electronic health records and/or national register data from 4 data sources in 3 European countries (Spain, Denmark and Finland). A background incidence rate will be applied prior to vaccination with the four-EMA approved COVID-19 vaccines. A self-controlled case series (SCCS) analysis will be conducted with all pregnant women with at least one COVID-19 vaccine dose (BioNTech/Pfizer, Moderna, AstraZeneca, J&J) during pregnancy and coagulation disorders diagnosis during pregnancy
• Study status:
  Planned

Research institutions and networks

Institutions

Real-World Evidence Team, University of Eastern Finland (RWE team)

Finland

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

University Medical Center Utrecht (UMCU)

Netherlands

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Agenzia regionale di sanità della Toscana (ARS)

Italy

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Teamit Institute

Spain

Study timelines

Date when funding contract was signed

Planned:28/05/2025

Actual:28/05/2025

Study start date

Planned:30/03/2026

Date of final study report

Planned:30/06/2026

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable