Parents report positive experiences about enrolling babies in a cord-related clinical trial before birth

Abstract

Aim: The aim of this study was to evaluate parents' perceptions when they were asked to enrol their unborn preterm infant in a randomised trial involving delayed cord clamping or cord milking.

Methods: The parents of 58 infants were asked to take part in a qualitative study using semi-structured interviews to provide feedback about how they felt about their infants being included in the research project. A total of 37 parents - 15 fathers and 22 mothers - agreed to take part.

Results: Parents were generally positive about their experiences of their baby taking part in the trial, but the findings raised some concerns about the validity of the consent obtained before delivery, as it was given in a hurry, and some participants had difficulty remembering that they had agreed to take part. Four themes were identified from the interviews: implications of taking part, reasons for enrolling infants, experiences of recruitment and suggestions for improvement.

Conclusion: Overall, the parents were positive about their baby taking part in the trial, but the consent process could be improved, by providing information about relevant trials earlier in the pregnancy or implementing continuous consent at key points in the trial.

Keywords: Informed consent; Interviews; Preterm; Randomised controlled trials.