Enrolment | Allocation | Post-allocation | ||||||
---|---|---|---|---|---|---|---|---|
Time point | 35-37 weeks gestation | 1st stage labour | During 2nd stage of labour | Immediately after allocation | 1-3 days | 6 weeks | 6 months | 12 months |
1st eligibility screen | X | |||||||
2nd eligibility screen | X | |||||||
Informed consent | X | X | ||||||
Allocation | X | |||||||
Intervention | X | |||||||
Assessments: | ||||||||
Labour and delivery | X | X | X | |||||
Operative delivery | X | |||||||
Perineal outcome | X | |||||||
Blood loss | X | |||||||
Maternal complications | X | X | ||||||
Hospital stay | X | |||||||
Readmission | X | |||||||
Neonatal outcomes | X | X | ||||||
Neonatal ICU admission(s) | X | X | ||||||
Satisfaction with birth | X | |||||||
Breastfeeding | X | X | X | |||||
Health-related quality of life | X | X | X | |||||
Pelvic floor | X | X | X | |||||
Depression | X | X | X |