Does offering a combination of video health and face-to-face visits for antenatal care result in improved patient experience and is it as safe as standard (face-to-face) care? A co-designed non-inferiority randomised controlled trial.

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. Women allocated to the intervention will have a combination of video-based telehealth and face-to-face visits (consumer led, a minimum of one up to a maximum of five telehealth visits and the remainder face-to-face), from 20 weeks gestation. The following is the expected schedule of visits for the intervention: 20-22 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. If 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 (taken at home prior to appointment) and acts upon if required. Duration 20 minutes. If midwife appointment face-to-face: 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 measures blood pressure and acts upon any abnormal findings. Duration 20 minutes 26-28 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. If telehealth*: 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 records symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes If 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. 30-31 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. 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 symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes. 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 any recent tests/ultrasounds 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. 34 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. 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 symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes. 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 any recent tests/ultrasounds 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. 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: Either midwife appointment telehealth OR midwife appointment face-to-face. 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 symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes. 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 any recent tests/ultrasounds 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. 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. The visits at 36, 40, and 41 weeks gestation will be face-to-face. 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. Each woman randomised to combined care will be shown how to self-measure their symphysis pubis fundal height and will be provided with written instructions and a video to support them with this. Women will be asked to measure their sysmphysis pubis funal height prior to each telehealth appointment. Each woman randomised to combined care will be provided with a blood pressure machine, shown how to use it by the research midwife, provided with written instructions, and asked to take her blood pressure before each telehealth appointment. Women will not need to decide their whole schedule in advance. The Government funded Health Direct portal, a free national encrypted web-based virtual public health service will be used for video-health calls. As it is a portal, women do not need to download an app, which is likely to increase ease of use and acceptability.