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Identifying Pregnancies in Population-Based Data Sources: Development and Application of the ConcePTION Pregnancy
Giorgio Limoncella1,2,3, Anna Girardi3, Claudia Bartolini3
1Department of Statistics, Informatics and Applications "Giuseppe Parenti", University of Florence, Florence, Italy.
Pharmacoepidemiology and Drug Safety
|August 9, 2026
Summary
The ConcePTION Pregnancy Algorithm (PA) successfully identified ~2.7 million pregnancies across 10 European data sources. This open-source tool aids in monitoring medication safety during pregnancy and breastfeeding.
Area of Science:
- Pharmacovigilance
- Reproductive Health
- Data Science
Background:
- Monitoring medication safety in pregnancy is crucial for maternal and infant health.
- Existing data sources often lack standardized methods for identifying pregnancies and their duration.
- The ConcePTION project aimed to improve pregnancy and breastfeeding medication safety monitoring.
Purpose of the Study:
- To describe the development and application of the ConcePTION Pregnancy Algorithm (PA).
- To identify pregnancies and estimate their duration in diverse European electronic healthcare data.
- To support multinational studies on medication safety in pregnancy.
Main Methods:
- Mapping 10 European data sources to the ConcePTION Common Data Model.
- Retrieving and reconciling pregnancy-related records into distinct pregnancy episodes.
- Utilizing a random forest model to estimate gestational age for incomplete records.
- Evaluating model performance using cross-validated Root Mean Squared Error (RMSE).
Main Results:
- The PA identified approximately 2.7 million pregnancies across over 2.2 million individuals.
- Pregnancy outcomes included live births (50%-83%), elective terminations (1%-15%), and spontaneous abortions (4%-10%).
- Gestational age was predicted for 6%-89% of records, with RMSE ranging from 17-50 days.
Conclusions:
- An open-source algorithm was developed to identify and date pregnancies, including early stages and those with unknown outcomes.
- The algorithm facilitates multinational research on the use and safety of medications during pregnancy.
- This tool enhances the generation of timely real-world evidence for pregnancy pharmacovigilance.
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