I read the paper by Hendrix et al.1 on a failed randomised trial of home birth in the Netherlands published in BJOG in March 2009 with interest. The authors refer to trial registration number NCT00237601.2 In the register, the study is described as an observational cohort study, although it is labelled as ‘a randomised controlled trial’ in the title. I would be grateful if the authors could explain the discrepancy between the title of the study and its description.
In a commentary attached to the paper, Emeritus Professor of Medical Ethics, Raanan Gillon, speculated on whether the recruitment to the abandoned trial might have been more offputting (rather than encouraging) than ethically necessary. According to the Helsinki Declaration, ‘each potential subject must be adequately informed of… the anticipated benefits and potential risks of the study’. I would be grateful if the authors could summarise the anticipated benefits and potential risks related to each trial arm as they were presented in the patient information sheets, and comment on Professor Gillon’s suggestion.