IMI ConcePTION WP2: Core data elements for pregnancy pharmacovigilance
The purpose of this documentation is to describe and define the core data elements required for the optimal assessment of the safety of in utero fetal exposure to medicines. Below we provide a reference framework for investigators utilising primary source data collection methods in pregnancy pharmacovigilance research.
The definitions and recommendations provided below have been developed through systematic review of established pregnancy pharmacovigilance datasets, with in depth critical review of the associated data dictionaries by clinical/non-clinical experts in the field of pregnancy pharmacovigilance and general pharmacovigilance.
The core data elements below are split into several tables of related elements, with each recommended element defined and described in terms of recommended data format, the expected source of the data, and the purpose of the data element.
Recommendations are also provided about whether the collection of core data elements should be considered essential for pregnancy pharmacovigilance purposes (columns 4a and 4b in the tables below). These core data elements are needed to allow for the optimal analysis of collected data. Whilst the collection of core data elements may be essential or highly recommended, the details may not always need to be directly reported in analysis outputs.
Please Note: The recommendations provided below will be regular reviewed and updated to ensure alignment with current practises in pregnancy pharmacovigilance research.
- Table 1: Database management details
- Table 2: Maternal details
- Table 3: Pregnancy details
- Table 4: Maternal medical history details
- Table 5: Family medical history and obstetric history details
- Table 6: Pregnancy medication exposure details
- Table 7: Maternal illness and obstetric complication details
- Table 8: Pregnancy outcome details
- Table 9: Delivery details
- Table 10: Live/stillborn birth outcome details
- Table 11: Live born neonatal/infant outcome details
- Table 12: Malformation details
- Table 13: Longer-term child health outcome details
- Table 14: Longer-term child neurodevelopmental outcome details
Inclusive language statement
We use the terms “women,” “woman,” “mother” and “maternal” throughout this documentation to refer to all those who are pregnant and give birth. We use these terms as it is highly important to be unambiguous and concise when providing recommendations for maternity, perinatal and postnatal health research (Gribble et al., 2022 – archived here). We acknowledge that not all people who are pregnant and give birth identify as women, and strongly support efforts to utilise inclusive language in medical and scientific research, and particularly in clinical practice.