Remote Telemedicine Fetal Monitoring Feasibility Study

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.

Conditions

• Pregnancy, High Risk
• Telemonitoring
• Telemedicine
• Ultrasound
• Cardiotocography

Interventions

DEVICE

Pregnabit Pro device and PregnaOne platform

Remote CTG device for pregnancy care

DRUG

Pulsenmore device

Remote ultrasound device for pregnancy care

Sponsors & Collaborators

• GE Healthcare

  collaborator INDUSTRY

• Nestmedic Spolka Akcyjna

  collaborator INDUSTRY

• Birmingham Women's NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Leo Gurney · Birmingham Women's and Children's NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-20

Primary Completion

2024-09-01

Completion

2024-09-20

Countries

• United Kingdom

Study Locations