Reasons for declining participation in a prospective randomized trial to determine the optimum mode of delivery of the preterm breech - PubMed (original) (raw)

Reasons for declining participation in a prospective randomized trial to determine the optimum mode of delivery of the preterm breech

Z J Penn et al. Control Clin Trials. 1990 Aug.

Abstract

Increasing numbers of preterm breech infants are being delivered by cesarean section, which confers no proven advantage to the infant and subjects the mother to increased risk. In order to assess the feasibility of performing a randomized controlled trial to compare elective with selective cesarean delivery for the preterm breech infant, consultants in 36 hospitals were asked if they would be willing to participate. In 25 hospitals all consultants agreed to participate, whereas in 11 universal support was not obtained. The reasons given for nonparticipation included the potentially time-consuming nature of the consent procedure, which it was proposed should be undertaken with all women during the antenatal period, concern that a large proportion of non-English speak women would not be able to give truly informed consent, anxiety about the seniority, availability, and requisite skill of the personnel delivering the preterm breech, doubts about the details of the protocol, medicolegal considerations, and disagreement about the desirability of the trial among the consultant members of a department. If prospective evaluation of clinical practice is to be carried out in the future the staffing levels of obstetric departments must taken into account the additional work load that this entails.

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