Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000536

EU PAS number

EUPAS1000000536

Study ID

1000000536

Official title and acronym

DARWIN EU® – Utilisation of commonly used benzodiazepines during pregnancy and the incidence of pregnancy losses

DARWIN EU® study

Yes

Study countries

Norway
Spain

Study description

Benzodiazepines are commonly prescribed for their anxiolytic, hypnotic, and sedative effects. Despite the use of benzodiazepines during pregnancy, there is limited evidence to support their use during this period or to favor their use over alternative treatments that may provide similar symptom relief with differing safety profiles. Understanding the patterns of benzodiazepine use during pregnancy in Europe, together with the rates of pregnancy losses, is essential for evaluating safety and effectiveness.
Despite detailed pregnancy information in many data sources, pregnancy episodes in electronic health record (EHR) data are often inconsistently coded across sources.
As part of the upcoming benzodiazepines periodic safety update report single assessment (PSUSA), the Pharmacovigilance Risk Assessment Committee (PRAC) has requested real-world evidence (RWE) on the utilisation of commonly used benzodiazepines during pregnancy.
Additionally, the background rates of pregnancy losses will be described to help contextualise the assessment of treatment safety during pregnancy.
To date, two data partners within the DARWIN EU® Data Network have pre-processed pregnancy episodes and developed a Pregnancy Extension Table (PET).
While the table has been successfully employed in other contexts, this study marks the first application of this table within the DARWIN EU® Data Network.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Julieta Politi

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
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C3-009_Bromazepam_V2.pdf

English (1015.03 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable