Study identification

EU PAS number

EUPAS1000000246

Study ID

1000000246

Official title and acronym

ADEPT: feasibility of estimating the risk of adverse pregnancy, neonatal and child outcomes following either in utero ASM exposure through the mother, or peri-conceptional ASM exposure through the father

DARWIN EU® study

No

Study countries

Finland
France
Italy
Netherlands
Norway
Spain
United Kingdom

Study description

This study seeks to assess the feasibility of estimating the risk of adverse pregnancy, neonatal and child outcomes after periconceptional maternal or paternal exposure to antiseizure medications (ASM), or in-utero ASM exposure, using data from 9 electronic healthcare databases in Europe.
This main objective has the following sub-objectives:
a. To estimate the availability of relevant information/characteristics for pregnant women, using the 15 different parameters that will inform the assessment of fitness for purpose.
b. To estimate availability of relevant information/characteristics for men and linkage with pregnancies, using 9 different parameters that will inform the assessment of fitness for purpose.
c. To estimate availability of relevant information/characteristics for neonates/children, using the following 17 parameters and comparing them between those that can and cannot be linked to mother and/or father where possible.
d. To assess fitness for purpose to different types of studies of pre conceptional/prenatal exposure to antiepileptics and the development of adverse pregnancy and child outcomes.

We will leverage data, human resources, expertise, methods, and infrastructures that are available in the EU PE&PV, ConcepTION, and VAC4EU networks. For this specific purpose, we included 9 pre-selected data sources from 7 countries whose data quality will be characterised using available INSIGHT tools (level 1-2 quality checks) that operate on the ConcePTION CDM structure. The source population comprises 48 million persons. This study will be conducted under the ENCePP code of conduct. The protocol, reports, code lists, clinical definition forms and phenotype algorithms, results and programs will be made publicly available with digital object identifiers in line with FAIR principles.

Study status

Ongoing
Research institutions and networks

Institutions

Utrecht University

Networks

Contact details

Miriam Sturkenboom 0000-0003-1360-2388

Primary lead investigator
ORCID number:
0000-0003-1360-2388

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable