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 lowrisk 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. ResultsThe 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.

Saving Lives at Birth: The Impact of Home Births on Infant Outcomes

“…The research comes entirely from medical studies using observational data as it proved impossible to randomize birth location (Dowswell et al 1996;Hendrix et al 2009). These studies generally compare average outcomes between samples of (low-risk) women planning to give birth at different types of location after controlling for observable characteristics.…”

Was the Dutch home birth trial properly registered and performed?

“…2,3 A clinically useful way to express this association is that a single treatment with cold-knife conisation or laser conisation resulted in about one perinatal death in every 70 pregnancies, 3 and large loop excision of the transformation zone (LLETZ) was associated with a lesser risk, of two perinatal deaths in 1000 pregnancies. 3 The more cervical tissue excised the greater the risk of preterm birth; cold-knife cone biopsy was associated with a higher risk than LLETZ, 2,3 and two treatments were associated with a higher risk than one. 1 The association between excisional cervical surgery and preterm delivery has been consistently reported in over 30 cohort studies.…”

“…1 The association between excisional cervical surgery and preterm delivery has been consistently reported in over 30 cohort studies. [2][3][4] It is biologically plausible that excising some of the cervix would weaken the physical and immunological barrier to infection ascending from the vagina into the fetal-placental unit, which is commonly seen and in preterm labour.…”

Nga Haerenga - The Journeys

“…The feasibility of undertaking a randomised controlled trial (to aim to provide evidence at that level) comparing place of birth was considered in the Netherlands where there is a high rate of home births (Hendrix et al, 2009). Researchers found that many women declined enrolment because they were unwilling to be assigned to a particular birth setting.…”