STUDY PERIOD | ||||
---|---|---|---|---|
Procedures | Enrolment | Allocation | Post-allocation | |
24 h after birth | Data taken from case notes after discharge | |||
ENROLLMENT | ||||
Assessment of eligibility criteria | X | X | ||
Signed consent form | X | |||
Randomisation | X | |||
INTERVENTIONS | ||||
Administration of study intervention (misoprostol or oxytocin for augmentation) | X | |||
ASSESSMENTS | ||||
Caesarean Birth | X | |||
Maternal complications | X | X | X | |
Fetal / neonatal complications | X | X | X | |
Serious maternal complications | X | X | X | |
Cost effectiveness | X | |||
Efficacy of induction process | X | |||
Assessment of adverse events | X | X | ||
Mother Generated Index | X | X | ||
Participant Satisfaction Questionnaire | X |