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Remote Telemedicine Fetal Monitoring Feasibility Study

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Contents

clinicaltrials.gov/study/NCT06366711
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT063667110
Health Conditions in Trial
Telemedicine
Telemedicine
0
Ultrasound
Ultrasound
0
Cardiotocography
Cardiotocography
0
Trial Recruitment Size
150
Trial Sponsor
Birmingham Women's NHS Foundation Trust
Birmingham Women's NHS Foundation Trust
0
Trial Collaborator
GE Healthcare
GE Healthcare
0
Clinical Trial Start Date
2024
0
Primary Completion Date
2024
0
Study Completion Date
2024
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Device Feasibility0
Intervention Type
Device0
Drug0
Interventional Trial Phase
Not Applicable0
Official Name
Remote Antenatal Maternal-fetal Telemedicine Monitoring in High-risk Pregnancies: a Feasibility and Acceptability Study0
Last Updated
April 16, 2024
0
Allocation Type
Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Pregnabit Pro device and PregnaOne platform0
Pulsenmore device0
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.

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