Progression criteria
| Feasibility objectives and related data to be collected | Go criteria to proceed to full trial | Criteria to reassess and adjust full trial protocol | Stop criteria |
| Study population | |||
| 1. Consent rates of eligible women | Rate >25% of eligible women agreeing to participate. | Rate between 11% and 24% women agreeing to participate | Rate <10% of eligible women agreeing to participate |
| Study outcomes | |||
| 2. Proportion of women in either intervention or control group for whom the allocated treatment is adhered to. | Adherence to allocated treatment in >80% of study sample. | Adherence to allocated treatment in between 51% and 79% of study sample. | Adherence to allocated treatment in <50% of study sample. |
| RCT processes | |||
| 3. Collection of data on clinical outcomes. | Complete data available of >80% of study sample. | Missing data between 21% and 49% of study sample. | Data missing of >50% of study sample. |
RCT, randomised controlled trial.