Testing the feasibility of conducting a randomised controlled trial (RCT) comparing standard (face-to-face) antenatal care with a combination of video health and face-to-face visits: a pilot RCT to inform a larger adequately powered study.

INTERVENTION: This study will have two arms – the intervention: combined video‐based telehealth and face‐to‐face pregnancy care; and the control: all face‐to‐face pregnancy care. For each trial arm the schedule for pregnancy visits will follow the routine schedule for each study site, the location for the visit will change depending on which trial arm the participant is allocated. The following is draft of the expected schedule of visits for the intervention: Intervention: Combined video‐based telehealth and face‐to‐face pregnancy care 20‐22 weeks gestation: Midwife appointment telehealth: Midwife reviews and discusses patients’ morphology ultrasound, if occurs prior to this appointment, organises further ultrasounds if required, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests if occurred prior to this appointment and organises further testing/management if required. Midwife organises gestational diabetes testing and any other testing appropriate to risk factors/indication prior to next appointment. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes 28 weeks gestation: Midwife appointment face‐to‐face: Midwife reviews and discusses patients’ morphology ultrasound if occurred post last appointment, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife r CONDITION: Pregnancy;Antenatal care; ; Pregnancy ; Antenatal care Reproductive Health and Childbirth ‐ Antenatal care PRIMARY OUTCOME: Composite outcome – proportion of participants who experience of any one (or more) of the adverse neonatal or maternal outcomes: ; • neonatal – preterm birth, small for gestational age after 37 weeks, fetal growth restriction after 37 weeks, macrosomia, term admission to Special Care Nursery/Neonatal Intensive Care, fetal death in utero, stillbirth, APGAR score less than 7 at five minutes post birth; ; • maternal– eclampsia, pre‐eclampsia with severe features (e.g., HELLP syndrome), uncontrolled diabetes, Intensive Care Unit/High Dependency Unit admission, death.; This will be measured by assessing routinely collected clinical data from electronic/medical records [At three months post birth of last baby in study] INCLUSION CRITERIA: Women with a singleton pregnancy attending either study sites as a public patient, planning to have their baby at study site and assessed as low obstetric risk, less than 24 weeks’ gestation, and able to speak and understand English. SECONDARY OUTCOME: Develop and test data collection tools that could be used for a future adequately powered RCT using specifically developed surveys at recruitment of participants and two months post birth of participants[Review data collection tools throughout pilot study, update as required and finalise two months post birth of final participant in pilot study ] Establish what other data would need to be collected (e.g. for costing the two trial arms) in the larger study by assessed by accessing patient electronic or paper medical record and reviewing data collection tools (recruitment survey and two month post birth survey)[Two months post birth of final participant in pilot study] Estimate costs and develop cost framework for larger RCT assessed by accessing patient electronic or paper medical records for costs of telehealth and face to face appointments and using specifically designed costing questions in two month post birth survey[Throughout pilot trial and two months post birth of final participant in pilot study ] Explore clinicians’ views of telehealth use using a specifically designed online survey for this study[Three months post closure of online survey (online survey will be closed four months after birth of last baby in the study)] Explore if the technology worked as planned assessed using questions specifically developed for this study[Assessed two months post birth of baby at telephone based survey] Explore if there is any obvious evidence of harm in providing telehealth for pregnancy care assessed by accessing patient electronic or paper medical records[Measured at birth] Explore potential primary clinical outcome/s for the larger randomisation control trial assessed by accessing patient electronic or paper medical records and discussing clinical outcomes with clinical experts[Two months post birth of final participant in pilot study] Investigate women’s satisfaction with their care (including what they did and did not like about telehealth and how it could be improved) using specifically designed questions for this study[Assessed two months post birth of baby at telephone based survey] Investigate women’s willingness to be randomised for a trial exploring telehealth for pregnancy care and the potential uptake of participation in a larger trial. Measured by collecting data during the recruitment period of number of eligible women and number of women who consented to be part of the study[Calculated post recruitment of all study participants (approximately two months post first randomisation)] To explore what percentage of the visits in both trial arms were conducted in the ‘place’ planned assessed by accessing patient electronic or paper medical records[Post birth of baby]