Supported by Pfizer (the study medication for the EPATH trial will be provided by Pfizer).
Information about the trial will be provided to women in the antenatal period or in early labour.
The ephedrine and placebo tablets taken during the n-of-1 trial will be provided by the sponsor at no cost to the patient.
Participants in the trial will be provided an information sheet about the study and asked to sign and date a consent form.
Full details on the design and methods of the MIND-DIA trial will be provided elsewhere (Petrak et al, in preparation).
Information about the trial will be provided to women and consent obtained in the antenatal period via the antenatal clinics, both in the community and maternity hospital, or in early labour in the delivery suite prior to the request for analgesia.
Pre-competitive research and drug prioritisation, early portfolio evaluation, cross-industry cooperation and multi-compound/sponsor trials are being explored, from which guidance for innovative trial designs will be provided.
Under the trial, $88,000 will be provided for a small drone equipped with a high-definition camera to stream live pictures back to Surf Life Saving WA operators at metropolitan and regional beaches.
Trial updates will be provided on the study website.
