Schedule of interventions and assessments
Study period (16 weeks to 8 weeks postdelivery) | ||||
Study visit | Trial entry/baseline | Antenatal follow-up | Notes review | Postnatal follow-up |
Time point | 20±4 weeks gestation | 30±3 weeks gestation | 40+4 weeks (postdelivery) | 40+8 weeks (postdelivery) |
Informed consent | X | |||
Eligibility assessment | X | |||
Demographics; including age, race, education | X | |||
Maternal demographics; including gestation, EDD and parity | X | |||
Patient Questionnaires; including EQ-5D-5L and STAI | X | X | X | |
Randomisation | X | |||
Recording home BP | Self-Monitoring group will record and submit reading between baseline and delivery | |||
Recording clinic BPs | X | |||
Maternal and perinatal outcomes | X | |||
Secondary outcome data | X | |||
Return of BP monitor | BP monitors will be returned at/or postdelivery |
BP, blood pressure; EDD, Estimated Delivery Date; EQ-5D-5L, EuroQoL 5 Dimensions 5 Levels; STAI, State-Trait Anxiety Inventory.