Clinical trials in Ireland are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004 (S.I. No. 190 of 2004), and amendments. In accordance with these Regulations, a clinical trial may only be started or conducted in Ireland if:
- an ethics committee has issued a favourable opinion;
- the Health Products Regulatory Authority (HPRA) has granted an authorisation, and;
- the trial sponsor, or legal representative of the sponsor, is established within the European Economic Area.
The trial referred to by the Deputy was authorised by the HPRA for conduct in Ireland in July 2020, following a favourable scientific assessment of the benefit/risk of the trial. The trial was also authorised by an ethics committee recognised by the Department of Health under the relevant legislation.
The trial involves an assessment of the use of two authorised methods of induction of labour, a medical device (Dilapan-S) and a medicine (dinoprostone, Propess). The trial population are normal risk nulliparous women at 39 weeks’ gestation with no medical complications, and who have no contraindications to the induction of labour. Subjects are randomised to different treatment groups, and administered the relevant treatment in hospital before returning home for 12-24 hours after initiation of induction of labour.
Published literature indicates that the induction of labour may have a role in accomplishing lower Caesarean section rates, reduced neonatal morbidity and mortality rates, and improved maternal experience. There is evidence to suggest that induction of labour at 39 weeks gestation may have these benefits; the trial seeks to identify the best method of achieving induction of labour in the patient population being studied.
I have asked officials in my Department to request further details from the Rotunda Hospital regarding the trial in question, and will reply directly to the Deputy once this information is received.
