2020

1. IDENTIFICATION & BASIC DESCRIPTION Cohort name   PRIDE Study Country   Netherlands Name   Marleen van Gelder Institution   Radboudumc Email   Marleen.vanGelder@radboudumc.nl Phone   +31-6-17598562 Do you want to add another Principal Investigator of the Cohort   Add another Principal Investigator of the cohort Name   Nel Roeleveld Institution   Radboudumc Email   Nel.Roeleveld@radboudumc.nl Website   www.pridestudy.nl Name of committee   Regional Committee on Research Involving Human Subjects (Arnhem/Nijmegen) Upload files   Van-Gelder_PPE_2013.pdf PRIDE-Study_PPE_2020.pdf Contact Principal Investigator (name)   Marleen van Gelder Data access policy (briefly describe)   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. Is this cohort part of a consortium? (name consortium)   N/A Participation in pooled analyses   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). Main aim of cohort, please briefly describe the main objectives of the cohort   Identification of factors that affect maternal and child health during of after pregnancy Study design (please select as many as appropriate)   Prospective cohort Nested case-control / Case-cohort Source population (please select as many as appropriate)   Mother-child cohort Generation (parents-children) study Comparators (please select as many as appropriate)   Internal study population Inclusion criteria   Maternal age at least 18 years, able to understand Dutch language Enrollment   Ongoing Age range at entry (main cohort)   Minimum Maximum Mean 18 47 30.7 Men at last follow-up   3045 Women at last follow-up   9054 Children (<18 years) at last follow-up   8146 Comments   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. 2. OUTCOME FOLLOW-UP Type of data for outcome follow-up (please select as many as appropriate)   Active (contact with participants) Hospital / physician diagnoses Active (contact with participants) (specify)   Web-based questionnaires Hospital / Physician diagnoses (specify)   Obstetric records, future plans to link to Baby Well Centers and GP records First follow-up period (provide year)   0 Last follow-up period (provide year)   18 Number of follow-ups after baseline (provide number)   18 (currently) Participation at last follow-up (if known)   80 Comments   Lost-to-follow up is considered lower than 20%, as many outcome data are retrieved from records when participants are lost-to-follow-up. 3. OCCUPATIONAL EXPOSURES Source of exposure data collected (please select as many as appropriate)   Questionnaire, Personal (Self-reporting or interview) Questionnaire, Personal (Occupational/industry modules) Occupational history/time frame   Other (specify) Specify: Other   At enrollment and changes throughout pregnancy Occupational coding performed   Yes Occupation (specify coding system used)   SOC2000 Types of exposure measurements   Biomarkers (see also section 5) Methods for exposure assessment (please select as many as appropriate)   GIS (other spatial methods) Job Exposure Matrix Self-report   Other Specify: Job Exposure Matrix / Other   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 Main categories   Solvents Pesticides Metals and metal oxides Other chemicals Psychosocial domains Organisation of work including working time Metals and metal oxides   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) Metals and metal oxides | Specify: Other   bronze, zinc Other chemicals | Anesthetic gases   Anesthetic gases Other chemicals | Detergents and cleaning products   Cleaning products Detergents Other chemicals | Engine exhaust   Diesel engine exhaust Gasoline engine exhaust Other chemicals | Second hand tobacco smoke at work   Second hand tobacco smoke at work (Environmental tobacco smoke - ETS) Psychosocial domains | Job task characteristics/organization of work   Job control, autonomy Psychological job demands Other (specify) Psychosocial domains | Job task characteristics/organization of work | Specify: Other   Job Strain questionnaire Organisation of work including working time | Employment conditions   Contract duration Work contract type (i.e. permanent, term-contract, subcontract, temporary) Organisation of work including working time | Shift work   Night (permanent or rotating) Rotating (not night) Organisation of work including working time | Working hours   Duration 4. OUTCOMES EVALUATED Baseline - type of outcome data collected (select more than one if applicable)   Medical records Questionnaire, individual (self-recording or interview) Follow-up - type of outcome data collected (select more than one if applicable)   Medical records Questionnaire, individual (self-recording or interview) Outcome type (please select as many as appropriate)   Morbidity Diagnostic groups based on ICD10   O+P Pregnancy and labour Q After birth – child disorders Other (specify) Other (specify)   We collect data on chronic conditions, infections, and maternal health after pregnancy, in all diagnostic groups. O+P Pregnancy and labour   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 Q After birth – child disorders   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 Q After birth – child disorders | Other (specify)   child growth and development throughout childhood, including but not limited to clinical diagnoses Other health related outcomes   Sleep 5. BIOLOGICAL SAMPLES & ANALYSIS Biological samples collected   Blood Other Specify: Other   saliva, feces Genetic and other lab analyses   Other (specify) Specify: Other   microbiome (feces) Comments   Samples are available from subgroups of participants, not for the complete study population. All samples are stored at -80oC fur future analyses. 6. Other Information   Alcohol Anthropometry Demographics Diet Education Environmental other (specify) Medical history Personality Physical exercise Residential history Socioeconomic status Smoking Other (specify) Specify: Environmental other   GIS possible Specify: Other   Medication, psychosocial stress Possibility for linkage to data registries/data enrichment via data linkage   Birth register Medication usage