Remote Telemedicine Fetal Monitoring Feasibility Study

Telemedicine Clinical Trial

Official title: Remote Antenatal Maternal-fetal Telemedicine Monitoring in High-risk Pregnancies: a Feasibility and Acceptability Study

Status Not yet recruiting

Clinical Trial Summary

During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited.

Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received.

Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research.

Clinical Trial Description

The primary aim of this research proposal is to explore the feasibility and acceptability of home antenatal maternal-fetal monitoring technology within a high-risk pregnancy group. The investigators hypothesise that home monitoring is feasible and acceptable to pregnant women.

Pregnant women from 32+0 weeks' gestation onwards receiving regular outpatient antenatal care including routine ultrasound and CTG monitoring on the Day Assessment Unit (DAU) at the Birmingham Women's hospital (BWH). They will continue their regular antenatal care whilst using the devices.

• Home antenatal CTG monitoring using the Pregnabit Pro device and PregnaOne platform only
• 5 participants.

• Home antenatal ultrasound monitoring using the Pulsenmore device only - 5 participants.

• Usage of both home antenatal ultrasound and CTG monitoring devices - 5 participants.

Following consent, participants will be provided with the home monitoring equipment including a face-to-face education session on their usage. A schedule for home monitoring will be agreed. Participants will be asked to complete a short questionnaire about their views and expectations of home telemetry, including some basic patient characteristics.

• Home CTG monitoring - Pregnabit Pro device and PregnaOne platform: Participants will be asked to use the remote monitoring devices twice a week, on mutually agreed days for a minimum of 30 minutes each time. Ideally participants will use the home CTG device for at least a four-week period or until delivery.

• Home ultrasound monitoring - Pulsenmore: Participants will be asked to use the remote monitoring devices fortnightly, on mutually agreed days . Ideally participants will use the home ultrasound device for at least a eight-week period or until delivery.

• Both home CTG and ultrasound monitoring: Participants will follow both above device plans as noted above

The recordings will be uploaded automatically and wirelessly to the respective online clinical dashboards, whereby two members of the research team will securely review the images contemporaneously.

End of participation:

Upon completion, equipment will be collected, and participants will be asked to complete a short exit questionnaire about the usability, reassurance, feelings of control and overall feedback. Additionally, patients will repeat the GAD-7 anxiety questionnaire.

End of study:

All data will be formally collated and analysed with respect to the above study outcomes, enabling the research team to retrieve an overall determination as to whether these devices are feasible and acceptable for the pregnancy population. ;

Related Conditions & MeSH terms

• Cardiotocography
• Pregnancy, High Risk
• Telemedicine
• Ultrasound

• NCT number: NCT06366711
• Study type: Interventional
• Source: Birmingham Women's NHS Foundation Trust
• Contact: Jack Hamer, MBChB
• Phone: 0121 472 1377
• Email: jack.hamer1@nhs.net
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Completion date: October 2024