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.

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 reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes 31-32 weeks gestation: Midwife appointment telehealth: Midwife 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 any recent tests/ultrasounds and organises further testing/management if required. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes 34 weeks gestation: Midwife appointment telehealth*: Midwife 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 any recent tests/ultrasounds and organises further testing/management if required. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes 36 weeks gestation: Midwife appointment face-to-face: Midwife 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/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If woman consents, midwife organises Group B Streptococcus testing. Duration 20 minutes. 38 weeks gestation: Midwife appointment telehealth: Midwife 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 any recent tests/ultrasounds and organises further testing/management if required. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes 40 weeks gestation: Midwife appointment face-to-face: Midwife 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/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes. 41 weeks gestation: Midwife appointment face-to-face: Midwife 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/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Midwife organises follow up for induction of labour planning as per hospital guidelines. Duration 20 minutes. *Where the woman is a negative blood group, this appointment will be made face-to-face to accommodate anti-D administration As telehealth visits will be conducted via video, routine physically examinations such as fundal height (measurement to monitor growth of the fetus), abdominal palpation for fetal position, auscultation of the fetal heart and blood pressure measurement will not be able to be undertaken during the appointment. Potential alternative arrangements for conducting these physical examinations (e.g. measurement of blood pressure at pharmacy or GP prior to telehealth appointment) will be guided by the processes currently in place at each study site. Adherence to the intervention will be assessed by auditing all participants electronic medical record or hospital administration record (site dependent) to assess if appointment was conducted on the above schedule and location (e.g., telehealth/face-to-face) as planned.