Improving detection of associations between congenital anomalies and medicines taken in the first trimester of pregnancy, using data derived hierarchies.

Study identification

• EU PAS number:
  EUPAS49055
• Study ID:
  49056
• Official title and acronym:
  Improving detection of associations between congenital anomalies and medicines taken in the first trimester of pregnancy, using data derived hierarchies.
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  France

  Ireland

  Italy

  Malta

  Netherlands

  Norway

  Poland

  Switzerland

  United Kingdom
• Study description:
  Identification of signals of potential harm is an important aspect of drug safety monitoring after regulatory approval. Current signal detection methods focus on the increased occurrence of single defects, but many teratogenic medications result in multiple defects. Different medications may also have similar patterns of associations with specific defects. Statistical methods to simultaneously analyse data on several birth defects and several medications within the EUROmediCAT database have been developed. These methods will be tested on EUROmediCAT data and results will be evaluated and interpreted by an advisory committee consisting of clinical specialists, pharmacologists and geneticist.
• Study status:
  Planned

Research institutions and networks

Institutions

St George's University of London

Networks

EUROmediCAT

Study timelines

Date when funding contract was signed

Planned:01/10/2021

Actual:01/10/2021

Study start date

Planned:01/10/2022

Date of final study report

Planned:01/09/2024

Sources of funding

Other

More details on funding

Medical Research Council (MRC)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable