| Enrolment | Allocation |  | Post-allocation | ||||
---|---|---|---|---|---|---|---|---|
Timepoint | 35-37 wks gestation | 1ststage labour | During 2nd stage of labour | Immediately after allocation | 1-3 days | 6 wks | 6 mths | 12 mths |
1st Eligibility screen | X | Â | Â | Â | Â | Â | Â | Â |
2nd eligibility screen | Â | X | Â | Â | Â | Â | Â | Â |
Informed consent | X | X | Â | Â | Â | Â | Â | Â |
Allocation | Â | Â | X | Â | Â | Â | Â | Â |
Intervention | Â | Â | Â | X | Â | Â | Â | Â |
Assessments: | Â | Â | Â | Â | Â | Â | Â | Â |
Labour and Delivery | Â | Â | X | X | X | Â | Â | Â |
Operative delivery | Â | Â | Â | Â | X | Â | Â | Â |
Perineal outcome | Â | Â | Â | Â | X | Â | Â | Â |
Blood loss | Â | Â | Â | Â | X | Â | Â | Â |
Maternal complications | Â | Â | Â | Â | X | X | Â | Â |
Hospital stay | Â | Â | Â | Â | X | Â | Â | Â |
Readmission | Â | Â | Â | Â | Â | X | Â | Â |
Neonatal outcomes | Â | Â | Â | Â | X | X | Â | Â |
NICU admission(s) | Â | Â | Â | Â | X | X | Â | Â |
Satisfaction with birth | Â | Â | Â | Â | Â | X | Â | Â |
Breast feeding | Â | Â | Â | Â | Â | X | X | X |
Health related quality of life | Â | Â | Â | Â | Â | X | X | X |
Pelvic floor | Â | Â | Â | Â | Â | X | X | X |
Depression | Â | Â | Â | Â | Â | X | X | X |