Why women do not accept randomisation for place of birth: feasibility of a RCT in The Netherlands

Abstract

Objective: The purpose of this study was to investigate why low-risk nulliparae were not willing to participate in a randomised controlled trial (RCT) of place of birth.

Design: Prospective study.

Setting: The Netherlands.

Population: All low-risk nulliparous women starting their pregnancy under midwife.

Methods: A questionnaire for 107 nulliparae who were willing to participate in a cohort study on place of birth, but at an earlier stage in their pregnancy declined to participate in a RCT of place of birth. This questionnaire included 12 items on a 4-point Likert scale but was not subjected to formal validation.

Main outcome measure: Reasons why nulliparae did not accept randomisation of place of birth.

Results: The most important reason why women refused participation in the trial was that they had already chosen their place of birth before they were asked to participate at 12 weeks of pregnancy. From their answers, it became clear that pregnant women strongly value their autonomy of choice. The decision not to participate in the trial was not influenced by the information given by the midwife and the additional written information.

Conclusions: Factors that prevent randomisation for place of birth are difficult to influence. There is a need to explore why there is such certainty of view among women having their first child. Until we have an understanding of why women select information to make these choices and why women are reluctant to participate in trials that challenge choice, it may well be impossible to mount a trial of place of birth.