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

06/11/2025
06/05/2026
EU PAS number:
EUPAS1000000812
Study
Ongoing
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Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000000812

Study ID

1000000812

Official title and acronym

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

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
France
Germany
Hungary
Netherlands
Norway
Portugal
Spain
Sweden
United Kingdom

Study description

Pregnant individuals are often excluded from clinical trials due to ethical reasons, and are, therefore, an important population to be included in post-approval risk management plans. Many observational healthcare databases contain detailed data related to the perinatal period. However, the use of the OMOP common data model (CDM) for perinatal research has been relatively limited.
Different algorithms to identify pregnancy episodes from claims and electronic health records (EHR) in native data format have been developed. However, their implementation in OMOP CDM data has been limited to databases in the US. Therefore, these algorithms can potentially be optimised and require validation prior to their implementation in different data sources.
This study will serve as a foundational step in determining the DARWIN EU® Data network’s capacity to support high-quality, population-based research in pregnancy and mother-child health, including regulatory, clinical, and epidemiological studies.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Talita Duarte-Salles

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable