1. IDENTIFICATION & BASIC DESCRIPTION |
Cohort name
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PRIDE Study
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Country
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Name
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Marleen van Gelder
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Institution
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Radboudumc
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Email
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Marleen.vanGelder@radboudumc.nl
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Phone
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+31-6-17598562
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Do you want to add another Principal Investigator of the Cohort
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- Add another Principal Investigator of the cohort
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Name
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Nel Roeleveld
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Institution
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Radboudumc
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Email
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Nel.Roeleveld@radboudumc.nl
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Website
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Name of committee
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Regional Committee on Research Involving Human Subjects (Arnhem/Nijmegen)
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Upload files
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Contact Principal Investigator (name)
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Marleen van Gelder
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Data access policy (briefly describe)
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The research question(s) of the project should be within the aim of the PRIDE Study and the participants' consent. Proposals for studies using data collected in the PRIDE Study will be discussed by the Steering Committee regarding feasibility, methodology, and overlap with ongoing projects. If approved, the PRIDE Study PI will prepare a Data Transfer Agreement and access will be invoiced according to the current price list. The variables necessary will be made available for analyses in the Digital Research Environment, a cloud-based secure access solution.
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Is this cohort part of a consortium? (name consortium)
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N/A
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Participation in pooled analyses
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- The cohort is potentially interested in participating in pooled analyses of (European) occupational cohort studies (note pooled analyses also includes remote decentralized analyses that would not require any transfer of primary data as well as meta-analyses).
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Main aim of cohort, please briefly describe the main objectives of the cohort
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Identification of factors that affect maternal and child health during of after pregnancy
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Study design (please select as many as appropriate)
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- Prospective cohort
- Nested case-control / Case-cohort
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Source population (please select as many as appropriate)
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- Mother-child cohort
- Generation (parents-children) study
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Comparators (please select as many as appropriate)
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- Internal study population
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Inclusion criteria
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Maternal age at least 18 years, able to understand Dutch language
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Enrollment
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Ongoing
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Age range at entry (main cohort)
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Minimum |
Maximum |
Mean |
18 |
47 |
30.7 |
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Men at last follow-up
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3045
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Women at last follow-up
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9054
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Children (<18 years) at last follow-up
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8146
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Comments
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Enrolment is ongoing. The numbers of particpants at last completed follow-up are based on the currently available analytical dataset, which includes all pregnancies with an estimated date of delivery in 2012-2019. Currently, over 12,000 pregnancies are included.
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2. OUTCOME FOLLOW-UP |
Type of data for outcome follow-up (please select as many as appropriate)
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- Active (contact with participants)
- Hospital / physician diagnoses
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Active (contact with participants) (specify)
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Hospital / Physician diagnoses (specify)
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- Obstetric records, future plans to link to Baby Well Centers and GP records
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First follow-up period (provide year)
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0
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Last follow-up period (provide year)
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18
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Number of follow-ups after baseline (provide number)
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18 (currently)
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Participation at last follow-up (if known)
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80
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Comments
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Lost-to-follow up is considered lower than 20%, as many outcome data are retrieved from records when participants are lost-to-follow-up.
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3. OCCUPATIONAL EXPOSURES |
Source of exposure data collected (please select as many as appropriate)
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- Questionnaire, Personal (Self-reporting or interview)
- Questionnaire, Personal (Occupational/industry modules)
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Occupational history/time frame
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Other (specify)
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Specify: Other
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At enrollment and changes throughout pregnancy
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Occupational coding performed
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Yes
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Occupation (specify coding system used)
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Types of exposure measurements
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- Biomarkers (see also section 5)
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Methods for exposure assessment (please select as many as appropriate)
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- GIS (other spatial methods)
- Job Exposure Matrix
- Self-report
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Specify: Job Exposure Matrix / Other
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Brouwers MM, van Tongeren M, Hirst AA, Bretveld RW, Roeleveld N. Occupational exposure to potential endocrine disruptors: further development of a job exposure matrix. Occup Environ Med 2009;66:607-614
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Main categories
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- Solvents
- Pesticides
- Metals and metal oxides
- Other chemicals
- Psychosocial domains
- Organisation of work including working time
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Metals and metal oxides
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- Aluminium
- Cadmium and all compounds
- Chromium (metallic chromium, Cr(iii), Cr(vi) and all compounds)
- Copper
- Iron (metallic iron and all compounds)
- Lead and all compounds
- Mercury, organic, inorganic
- Other (specify)
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Metals and metal oxides | Specify: Other
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bronze, zinc
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Other chemicals | Anesthetic gases
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Other chemicals | Detergents and cleaning products
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- Cleaning products
- Detergents
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Other chemicals | Engine exhaust
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- Diesel engine exhaust
- Gasoline engine exhaust
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Other chemicals | Second hand tobacco smoke at work
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- Second hand tobacco smoke at work (Environmental tobacco smoke - ETS)
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Psychosocial domains | Job task characteristics/organization of work
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- Job control, autonomy
- Psychological job demands
- Other (specify)
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Psychosocial domains | Job task characteristics/organization of work | Specify: Other
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Job Strain questionnaire
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Organisation of work including working time | Employment conditions
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- Contract duration
- Work contract type (i.e. permanent, term-contract, subcontract, temporary)
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Organisation of work including working time | Shift work
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- Night (permanent or rotating)
- Rotating (not night)
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Organisation of work including working time | Working hours
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4. OUTCOMES EVALUATED |
Baseline - type of outcome data collected (select more than one if applicable)
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- Medical records
- Questionnaire, individual (self-recording or interview)
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Follow-up - type of outcome data collected (select more than one if applicable)
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- Medical records
- Questionnaire, individual (self-recording or interview)
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Outcome type (please select as many as appropriate)
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Diagnostic groups based on ICD10
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- O+P Pregnancy and labour
- Q After birth – child disorders
- Other (specify)
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Other (specify)
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We collect data on chronic conditions, infections, and maternal health after pregnancy, in all diagnostic groups.
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O+P Pregnancy and labour
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- Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
- Excessive vomiting in pregnancy
- Infections of genito-urinary tract in pregnancy
- Diabetes mellitus in pregnancy
- Other specified pregnancy-related conditions
- Preterm delivery
- Extremely low birth weight
- Other low birth weight
- Exceptionally large baby
- Birth trauma
- Congenital viral diseases
- Foetal death of unspecified cause
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Q After birth – child disorders
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- Congenital malformations of the nervous system incl. the brain
- Congenital malformations of the circulatory system
- Congenital malformations of the respiratory system
- Cleft lip and cleft palate
- Congenital malformations of digestive system
- Congenital malformations of genital organs
- Congenital malformations of the urinary system
- Congenital malformations and deformations of the musculoskeletal system
- Down's syndrome
- Turner's syndrome
- Klinefelter's syndrome
- Other, please state
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Q After birth – child disorders | Other (specify)
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child growth and development throughout childhood, including but not limited to clinical diagnoses
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Other health related outcomes
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5. BIOLOGICAL SAMPLES & ANALYSIS |
Biological samples collected
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Specify: Other
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saliva, feces
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Genetic and other lab analyses
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Specify: Other
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microbiome (feces)
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Comments
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Samples are available from subgroups of participants, not for the complete study population. All samples are stored at -80oC fur future analyses.
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6. Other Information |
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- Alcohol
- Anthropometry
- Demographics
- Diet
- Education
- Environmental other (specify)
- Medical history
- Personality
- Physical exercise
- Residential history
- Socioeconomic status
- Smoking
- Other (specify)
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Specify: Environmental other
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GIS possible
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Specify: Other
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Medication, psychosocial stress
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Possibility for linkage to data registries/data enrichment via data linkage
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- Birth register
- Medication usage
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