The ConcePTION demonstration projects using existing healthcare data
We need data to study medication in pregnancy. The ConcePTION project has developed innovative methods and strategies for using existing data or secondary data sources. The project updated and extended the existing EUROmediSAFE inventory by adding data sources within and outside the EU. The ConcePTION project also designed and conducted case-non case control studies based on EUROmediCAT, and cohort studies using multiple data sources.
It is estimated that at least one medication is used in 90% of pregnancies. Meanwhile, only 4% have information regarding the benefits and risks when used during pregnancy. The ConcePTION drug utilisation studies have produced innovative methods and strategies for using secondary data sources to determine specific medicine use.
The ConcePTION project has developed algorithms that can support identification and characterisation of pregnancies where the mother is affected by a specific disease through secondary data sources. These secondary data sources include population healthcare databases for operational healthcare use. For example, prescription data, primary care data, maternity data, hospital discharge data and medical birth registries. But also, disease registries and birth cohorts collected for research and surveillance purposes.
The ConcePTION project has defined a standard core set of clinically relevant maternal, perinatal and childhood variables for secondary database studies. These have been evaluated to adequately address regulatory requirements to inform health care providers and patients on medication use during pregnancy for example through medication labels.
Demonstration studies
Reliable evidence generated from sound and robust scientific medication safety studies in pregnancy using real-world data can have important implications for clinical practice, as it enables pregnant people and health care providers to make informed treatment decisions. Five innovative demonstration projects were performed covering specific diseases and treatments using secondary data sources to tackle challenges in the use of such data and to provide guidance to future researchers undertaking similar studies. The study protocols were uploaded to the EU PAS register and are available in Deliverable 1.3 on the ConcePTION website and on Zenodo.
The scientific findings of the five demonstration studies are reported separately in Deliverable 1.6 (not yet published). Here follows some of the titles:
- Pregnancy and infant outcomes in gestationally-diagnosed breast cancer. A pilot study in Finland and Norway from the IMI ConcePTION project explored alternative assessment windows, diagnostic code values and alternative uses such as off-label.
- Reason for gabapentinoids prescribing in pregnancy. Results from six European countries. A contribution from the IMI2 ConcePTION project.
- Gabapentinoid exposure in early pregnancy and risk of congenital anomalies: an IMI ConcePTION European case malformed control study.
- A systematic review of gabapentinoids use during pregnancy and effects on pregnancy and childhood outcomes. An IMI ConcePTION study.
- A European case-malformed control study assessing maternal exposure to antidepressants in the first trimester of pregnancy and risk of congenital anomalies: A contribution from the ConcePTION project.
- Identifying women of childbearing age with Multiple Sclerosis in six European healthcare data sources: A contribution from the IMI ConcePTION project.
- Specific congenital anomalies associated with maternal Multiple Sclerosis. A ConcePTION European case malformed control study.