The primary aim of the trial is to assess the feasibility of undertaking a full-scale phase III cluster trial. This decision will be based on the acceptability of the trial using a composite assessment of both quantitative and qualitative data, and will include assessment of the following:
- whether the trial is appealing to women (via assessment of the recruitment rate to ensure a full-scale phase III trial is feasible).
- whether the intervention is acceptable.
- whether the intervention has any adverse impact on infant immunisation rates.
- the number of women who complete the trial and complete the trial questionnaires.
We also wish to measure the extent of any intervention contamination, obtain data to help inform the sample size calculations for the phase III trial and assess the acceptability/validity of the ICECAP for the cost-effectiveness analysis for the phase III trial.