Oral Presentation ESA-SRB 2023 in conjunction with ENSA

Therapeutic development for pregnancy – a crisis that can no longer be ignored (#109)

Natalie Hannan 1
  1. University of Melbourne; Mercy Hospital for Women; The Northern Hospital, Heidelberg, VIC, Australia

Major obstetric complications including preterm birth, preeclampsia, fetal growth restriction and stillbirth are the leading cause of perinatal morbidity and mortality globally. Death from obstetric complications disproportionately affects pregnancies in low and middle-income countries and communities. Critically these complications lack appropriate effective treatments.

Pregnant and breastfeeding women are ‘therapeutic orphans’. They are systematically excluded from therapeutic research, development, and clinical trials. Predominantly this is due to fear of harm to the neonate. Furthermore, the majority of medications used in pregnancy are used ‘off-label’ due to lack of appropriate understanding of any potential harmful effects in pregnancy, or the passage of drugs to the neonate and especially whether there are teratogenic consequences. While our risk aversion is understandable, and there have been efforts to improve inclusion of pregnant populations in clinical trials, progress remains stagnant. We can no longer ignore this crisis; appropriate inclusion of pregnant women in research, development and clinical trials of therapeutic agents is urgently needed.

Our team has a dedicated focus towards advancing our knowledge of therapeutic actions during embryo implantation, placentation, and maternal vascular adaptation in pregnancy, as well as focusing on treating the underlying pathophysiology of major obstetric complications. We have carefully developed a novel preclinical pipeline for sophisticated therapeutic development, utilising primary human tissue assays and mouse models to test innovative therapeutic strategies, to examine new drugs and innovative delivery methods.

Importantly the novel strategies we are developing are focused on clinical translation and offer exciting possibilities to enhance equity of access for therapeutic development for pregnancy and vitally the future treatment of obstetric diseases.