Secondary objectives
blood transfusions
SECONDARY, RECRUITMENT
The secondary study objectives are as follows:Identify barriers and facilitators to participation in the trial, including assessing reasons for refusal, from study participants, clinicians and, where possible, those unwilling to participate.Assess retention rates of participants throughout pregnancy in both arms of the study.Identify reasons for attrition.Assess the willingness of clinicians to recruit into this trial.Assess the proportion from the control arm advised clinically to start prophylactic blood transfusion.Measure clinical outcomes for women and infants including an initial preliminary assessment of efficacy for a future definitive trial.Generate data to inform the design of a definitive trial, including identifying the primary outcome and sample size for the definitive trial.Record safety issues around blood transfusions in both arms of the study.Identify strategies to optimise recruitment and retention.Assess the acceptability of the intervention, trial procedures and conduct, including identifying the core outcomes that are considered important to measure.Assess participants’ experience of taking part in the study.Explore the cost implications of the proposed intervention and to assess measurement tools and methods.Assess two widely used HRQoL measures against each other.