Was the Dutch home birth trial properly registered and performed?
Article first published online: 6 JUL 2010
© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 117, Issue 9, pages 1162–1163, August 2010
How to Cite
Olsen, O. (2010), Was the Dutch home birth trial properly registered and performed?. BJOG: An International Journal of Obstetrics & Gynaecology, 117: 1162–1163. doi: 10.1111/j.1471-0528.2010.02610.x
- Issue published online: 6 JUL 2010
- Article first published online: 6 JUL 2010
- Accepted 14 April 2010.
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.
- 2Home or Hospital Birth, Does it Really Matter? A Randomised Controlled Trial. 2005 Oct 11 [changed 2009 Apr 07; cited 2009 Nov 26]. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Available from: http://clinicaltrials.gov/ct2/show/study/NCT00237601., .