Dr Charlotte Haunton1,2, Associate Professor Stephen C Kane3,4, Associate Professor Amanda Henry5,6
1Department of Obstetrics & Gynaecology, Royal Prince Alfred Hospital, Camperdown, Australia, 2University of Sydney, Camperdown, Australia, 3Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Australia, 4Department of Maternal Fetal Medicine, The Royal Women's Hospital, Parkville, Australia, 5School of Women's and Children's Health, University of New South Wales, Randwick, Australia, 6Department of Obstetrics & Gynaecology, St George Hospital, Kogarah, Australia
Biography:
Biographies to come
Abstract:
Background: Almost all pregnant women will require medication, with up to 97% using at least one medication, and 30% using five or more.[1] It is well established that pharmacological trials specifically designed for the pregnant population are underrepresented, accounting for only 0.32% of clinical trials globally, a substantially lower proportion than for other conditions of comparable incidence or cost.[2]
Aims: To examine the frequency with which pregnant women are eligible for inclusion in general (non-pregnancy-specific) medication trials performed in areas relevant to pregnancy, in order to provide current data on the relative underrepresentation of pregnant participants.
Methods: Three clinical trial registries (Clinicaltrials.gov, the European Union Clinical Trials Register and the Australia and New Zealand Clinical Trials Register) were searched for trials registered from 01/01/2023-01/01/2024 including women of child-bearing age in the following medication categories: antibiotics, antihypertensives, antidiabetics. Trials were excluded if they involved medications known to be teratogenic, addressed age-related diseases uncommon in women of child-bearing age, or if the comparator was surgical management.
Results: A total of 157 relevant (antibiotics, antihypertensives, antidiabetics) trials were identified. Overall, 8.9% (14) of trials included pregnant participants, of which the majority (11) were specifically pregnancy-related medication trials. Only 3 (1.9%) general, non-pregnancy-related trials did not exclude pregnant participants (1 study examining antibiotics, 2 studies examining antidiabetics). Two of the 14 total trials were phase 1; the remaining studies were phase 2-4.
Conclusion: Pregnant women are underrepresented in trials of antibiotics, antihypertensives and antidiabetics, with the overwhelming majority of general medication trials listing pregnancy as an exclusion criterion, and only a small proportion specifically examining a pregnant population. There is a need for further advocacy, incentives, and policy change to increase the inclusion of pregnant women in medication trials, and therefore address the present lack of data on medication safety in pregnancy.
Keywords
Clinical trials, drug safety, pregnancy
References
1. Haas DM, Marsh DJ, Dang DT, et al. Prescription and other medication use in pregnancy. Obstet Gynecol. 2018;131(5):789-798.
2. Scaffidi J, Mol BW, Keelan JA. The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy. BJOG. 2017;124(1):132-140.