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Assessment of Prescribed Drugs and Associated Risk During Pregnancy

France, 2004 - 2017
Reference ID
FRESH-PEF60124-en
Producer(s)
Isabelle Lacroix, Christine Damase-Michel
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Data Access
  • Contacts
  • Metadata production

    • Identification

    Survey ID number

    FRESH-PEF60124-en
    Title

    Assessment of Prescribed Drugs and Associated Risk During Pregnancy
    Abbreviation or Acronym

    EFEMERIS
    Country
    Name
    France
    Abstract

    To form a cohort of pregnant women in monitoring the registration of medication prescribed and dispensed (during pregnancy) and the outcome of these pregnancies, so as to investigate the potential effects of exposure to drugs on newborns (prematurity, malformations, neonatal pathologies, psychomotor development).
    Kind of Data

    ['Clinical data','Socio-demographic data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Gynaecology and obstetrics health theme
    Paediatrics health theme
    cim-11 http://id.who.int/icd/entity/744313508
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    newborns neonatal diseases congenital anomalies pregnancy drugs psychomotor development pharmacology abortions

    Coverage

    Geographic Coverage

    ['Occitanie']
    Universe

    {
    "level_sex_clusion_I": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Infant (28 days to 2 years)",
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)"
    ],
    "level_type_clusion_I": [
    "General population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Isabelle Lacroix
    Christine Damase-Michel
    Producers
    Name Role
    CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT) sponsor
    Funding Agency/Sponsor
    Name
    AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)

    Study authorization

    Agency
    Agency name
    CNIL

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.) Medical-administrative database (patients, health insurance/mutual insurance)']
    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2004 2017
    Time Method

    Longitudinal or cohort study
    Mode of data collection
    • Other

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services

    Data Access

    Access conditions

    Contact the principal investigator
    Availability Status

    To be defined

    Contacts

    Contacts
    Name Email
    Isabelle Lacroix medrepro@chu-toulouse.fr
    Christine Damase-Michel medrepro@chu-toulouse.fr

    Metadata production

    DDI Document ID

    FRESH-PEF60124-en
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