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, page 1163, August 2010
How to Cite
Hendrix, M. and Nijhuis, J. (2010), Was the Dutch home birth trial properly registered and performed?. BJOG: An International Journal of Obstetrics & Gynaecology, 117: 1163. doi: 10.1111/j.1471-0528.2010.02616.x
- Issue published online: 6 JUL 2010
- Article first published online: 6 JUL 2010
- Accepted 15 April 2010.
In a Letter to the Editor, Ole Olsen1 asked why there was a discrepancy between the title and the description of the study in the trial registration number (NCT00237601). As we described in our paper,2 the study was originally started as a randomised controlled trial (RCT) for place of birth. However, the recruitment process of the pregnant women was certainly not what we had expected based on a pilot study. After investigating the reasons for not participating in the RCT (which were described in the paper), we changed our study design to an observational cohort study. We made these changes within the same registration, and therefore the reference number of our study did not change. At that time, we should also have changed the title of our study.
In the patient information sheets, we presented both trial arms: home birth and short-stay hospital birth. All pregnant women were familiar with the choice between a ‘home’ and ‘home-like’ delivery in a hospital under supervision of a midwife. Low-risk pregnant women were free to choose where to give birth, at home or in a short-stay hospital setting. Obviously, there were no clear benefits or risks related to each trial arm. In the patient information sheets, we explained that low-risk nulliparae had a 50% risk of being referred to the obstetrician during delivery. Furthermore, we described that both birth-giving places were safe and that the pregnant women would receive the usual obstetric care they needed during pregnancy and delivery.
Professor Gillon discussed whether the midwives and researchers encouraged potential candidates to participate in the trial. For the researchers, it is unclear as to what degree the midwives positively encouraged the pregnant women to participate in the trial. However, the results of the study showed clearly that women had already made their choice where to give birth before they were asked to participate in the trial. Furthermore, they wanted to keep their autonomy and they preferred to make their own decisions. Because of the fact that both home births and short-stay hospital births are common practices in the Netherlands, and based on the results of our study, we concluded that a RCT for place of birth was not feasible in the Netherlands. We do not expect that a more encouraging attitude would have influenced this conclusion.