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Research on medication safety in pregnancy at Ulster University’s Centre for Maternal, Fetal and Infant Research has directly impacted regulatory and clinical guidelines on prescribing medicines to women with depression, diabetes, and epilepsy in pregnancy.

  • Influenced and informed the European Medicines Agency’s decision to make pharmaceutical companies add warnings to the packaging of the antiepileptic drug, sodium valproate, on the risks to the unborn child  of taking this drug in pregnancy.
  • Influenced and informed national and international clinical guidelines (NICE) on the safety of medications in pregnancy for women with depression, diabetes and epilepsy.
  • Research Context 

    Women with chronic conditions such as depression, diabetes and epilepsy need medications to treat their condition. However, there is little information on the safety of these medications during pregnancy as pregnant women are rarely included in clinical trials.

    Our research on the risk of congenital anomalies (sometimes known as “birth defects”) in the unborn child associated with maternal medication exposure in the first trimester of pregnancy helped bridge this gap in knowledge, by analysing our large European database of congenital anomaly cases. We provided essential evidence for regulators and health care providers who wish to provide safe and effective treatment to pregnant women with chronic health conditions while simultaneously decreasing potential risks that the medication may pose to the unborn child.

  • Sources To Corroborate 
    • Enquête relative aux spécialités pharmaceutiques contenant du valproate de sodium. Février 2016, Inspection générale des affaires sociales (IGAS) Rapport No 2015-094R, p 121. French language item.
    • European Medicines Agency report (2018).
    • Sodium Valproate patient information leaflet.
    • National Institute for Health and Care Excellence (2015). “Antenatal and postnatal mental health. Clinical management and service guidance”. Updated edition. National Clinical Guideline Number 192, p734, 746.
    • National Institute for Health and Care Excellence “Spotlight on valproate prescribing”, which is part of the NICE Impact Report on Maternal and Neonatal Care (Sept 2019), p 16. Associated NHS Business Services Authority sodium valproate prescribing data up to July-September 2020.
    • British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum: Journal of Psychopharmacology 2017. Vol 31 (5), p536.
    • “The Maudsley Prescribing Guidelines in Psychiatry”, 2018. 13th Edition, Wiley Blackwell, Oxford (p 606).
    • UK Teratology Information Service Monographs (available in TOXBASE) for use by heath care professionals. Our research is cited in the “Selective Serotonin Re-uptake Inhibitors (SSRIs) in Pregnancy” monograph, issued in 2017 (p5).
    • Report of the WHO Expert Committee, 2017 “The Selection and Use of Essential Medicines”. (WHO Collaborating Centre in Evidence-Based Research Synthesis and Guideline Development) (p 50).
    • American College of Obstetricians and Gynecologists Practice Bulletin No. 201 (2018); Vol 132 (6). Pregestational Diabetes Mellitus (p e236).