Parents Perception of giving antenatal consent to include their preterm infant into a randomized controlled trial (RCT)
Aims: RCTs have shown that a slight delay in clamping the cord enables placento-fetal transfusion, which benefits preterm infants greatly by reducing intraventricular hemorrhages and the need for blood transfusion. An ethical problem with performing such study is to obtain consent from parents at a time when they are very vulnerable and stressed. Objective: To evaluate parents perception of including their unborn infant <33 weeks gestation into a RCT on a slight delay in clamping the cord of 30s or four times milking the cord. Design/Method: Prospective, single centre study. Parents, whose infants had been entered in to the RCT, were offered to take part in a structured interview. The interviews were recorded and transcribed. The interview analysis was performed by a researcher, blinded to the infants allocation, by using NVivo software. Analysis was then summarized by systematic thematic analysis. Results: 37 (31.9%) of 116 eligible parents agreed to take part in the interviews (22 female, mean age 29.9 years (19–41), 15 male mean age 33.12 years (21–46)). The results identified five main themes: (i) timing of recruitment; (ii) reasons for participating in the RCT; (iii) implications of taking part; (iv) professionalism of staff (including attitude, care and information giving); and (v) suggestions for improvement. The results were then correlated with the infants CRIB score after. On the basis of the whole sample there was no difference in infants CRIB scores between milking the cord (mean 2.52; SD 3.19; n=27) and delaying clamping the cord (mean 2.75; SD 4.15; n=28). Conclusions: The delivery of a preterm baby can be very stressful, but parents were prepared to enrol their unborn baby into the trial, if they had the time to think about it and expressed gratitude towards staff. Our study demonstrates that it is possible to conduct a RCT with consent before birth.
The Study was supported by a Sussex R&D grant.