DARWIN EU® - Enabling pregnancy and mother-child research in DARWIN EU® Data Network - PeriNet

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Feasibility analysis

  Method development or testing

  Validation of study variables (exposure outcome covariate)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  The study population included all individuals registered as female sex (at data source entry) present in the data source during the study period. ; Inclusion criteria ; • All individuals who were present in the period from 01/01/2010 to 31/12/2024 (or the latest date ; of data availability) ; • Participants were female sex (at data source entry) ; • Aged 15 to 55 years ; • Minimum 365 days of continuous data source history were available ; • At least one record indicative of a pregnancy episode occurred up to 31/12/2023 (or one year before the data source end date), to ensure full-term pregnancies could be identified.
• Special population of interest:
  Pregnant women

Study design details

• Main study objective:
  1. To identify data partners in the DARWIN EU® Data Network with available data on pregnancy, pregnancy start and end dates, pregnancy outcomes and mother and child linkage.; 2. To optimise and validate OMOP pregnancy algorithms for Darwin EU® databases with pregnancy-related data.; 3. To establish a convention for the mapping of pregnancy-related data and mother and child linkage data to the OMOP CDM, exploring the use of the Perinatal Extension Table (PET).; 4. To characterise pregnancies and mother-child linkage over time for Darwin EU® databases with pregnancy-related data.; 5. To create a database with aggregate counts related to pregnancy and mother-child linkage to support feasibility assessment.