| Study period | ||||
---|---|---|---|---|---|
Enrolment | Intervention | Follow-up | |||
Timepoint | < 22 weeks GA | < 25 weeks GA | < 36 weeks GA | 6 weeks postnatally | 6 months postnatally |
Enrolment | |||||
 Eligibility screen | X |  |  |  |  |
 Informed consent | X |  |  |  |  |
 Random allocation | X |  |  |  |  |
Interventions | |||||
 Early US |  | X |  |  |  |
 Early US with messages |  | X |  |  |  |
 Early and late US with messages |  | X | X |  |  |
Assessments: baseline and antenatal | |||||
 Socio-demographic questionnaire | X |  |  |  |  |
 Fetal growth assessment |  | X | X |  |  |
 Social support |  | X | X |  |  |
 Maternal and paternal antenatal depression and anxiety |  | X | X |  |  |
 Maternal and paternal antenatal attachment |  | X | X |  |  |
 Maternal and paternal antenatal depression |  | X | X |  |  |
 US experiences questionnaire |  | X | X |  |  |
Outcomes: primary and secondary | |||||
 Bayley Scales of Infant and Toddler Development, Third Edition |  |  |  |  | X |
 Home Screening Questionnaire |  |  |  |  | X |
 Mother/father–infant interaction |  |  |  |  | X |
 Perinatal and postnatal information |  |  |  | X |  |
 Infant behaviour (crying, sleeping, etc.) |  |  |  | X |  |
 Breastfeeding practices questionnaire |  |  |  | X | X |
 Maternal and paternal postnatal depression and anxiety |  |  |  | X | X |
 Social support |  |  |  | X | X |
 Partner involvement |  |  |  | X | X |
 Infant growth – weight and length |  |  |  | X | X |
 Immunisation status |  |  |  | X | X |
 Clinic attendance |  |  |  | X | X |