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Aim and Design of pREGnant, the Dutch Pregnancy Drug Register

Author

Listed:
  • Saskia Vorstenbosch

    (Netherlands Pharmacovigilance Centre Lareb)

  • Bernke Winkel

    (Netherlands Pharmacovigilance Centre Lareb)

  • Marleen M. H. J Gelder

    (Radboud University Medical Center
    Radboud University Medical Center)

  • Agnes Kant

    (Netherlands Pharmacovigilance Centre Lareb)

  • Nel Roeleveld

    (Radboud University Medical Center)

  • Eugène Puijenbroek

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen)

Abstract

Information on the safety of medication use during pregnancy and breastfeeding is scarce, yet use of medication among pregnant and breastfeeding women is widespread. The pREGnant, the Dutch Pregnancy Drug Register, was set up to obtain insight into medication use among pregnant and breastfeeding women and potential effects on maternal and fetal/infant health. The systematically documented, good quality data on medication use during pregnancy and lactation in pREGnant will be used in signal detection, epidemiologic studies and counseling of healthcare providers and patients. The register has a prospective cohort design. The population is derived from pregnant women throughout the Netherlands. Data collection started in April 2014 and enrollment of women is continuous and is characterized by a relative high proportion of women born in the Netherlands with a high education compared with the general Dutch pregnant population. Data on current pregnancy, obstetric history, maternal lifestyle, health and medication use, delivery, and infant health are collected through web-based questionnaires completed by the participating women (three times during pregnancy and three times during the infant’s first year of life). If permission is given, the self-reported data can be complemented with information retrieved from Perined, the perinatal registry of the Netherlands, and from obstetric and medical records, and/or pharmacy records. Here, we provide detailed information on the design of the pREGnant, the Dutch Pregnancy Drug Register, as well as descriptive information on characteristics of the participants so far. Currently, steps are being taken to implement the register on a large scale in the Netherlands.

Suggested Citation

  • Saskia Vorstenbosch & Bernke Winkel & Marleen M. H. J Gelder & Agnes Kant & Nel Roeleveld & Eugène Puijenbroek, 2019. "Aim and Design of pREGnant, the Dutch Pregnancy Drug Register," Drug Safety, Springer, vol. 42(1), pages 1-12, January.
    • Handle: RePEc:spr:drugsa:v:42:y:2019:i:1:d:10.1007_s40264-018-0722-7
    DOI: 10.1007/s40264-018-0722-7
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    Cited by:

    1. Michael Ceulemans & Kristel Van Calsteren & Karel Allegaert & Veerle Foulon, 2022. "Information Needs and Counseling Preferences among Potential Users of the Future Teratology Information Service in Belgium: A Cross-Sectional Study Involving the Public and Healthcare Professionals," IJERPH, MDPI, vol. 19(14), pages 1-14, July.
    2. Jonathan L. Richardson & Alan Moore & Rebecca L. Bromley & Michael Stellfeld & Yvonne Geissbühler & Matthew Bluett-Duncan & Ursula Winterfeld & Guillaume Favre & Amalia Alexe & Alison M. Oliver & Yrea, 2023. "Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project," Drug Safety, Springer, vol. 46(5), pages 479-491, May.
    3. Annerose E. van der Mijle & Petra J. Woestenberg & Leanne J. Kosse & Eugène P. van Puijenbroek, 2023. "The Dutch Pregnancy Drug Register: Suitable to Study Paternal Drug Exposures?," IJERPH, MDPI, vol. 20(23), pages 1-9, November.

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