Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366711
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-28
Brief Title:
Remote Telemedicine Fetal Monitoring Feasibility Study
Sponsor:
Birmingham Womens NHS Foundation Trust
Organization:
Birmingham Womens NHS Foundation Trust
Study Overview
Official Title:
Remote Antenatal Maternal-fetal Telemedicine Monitoring in High-risk Pregnancies a Feasibility and Acceptability Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mothers blood pressure and urine recording the babys 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 babys 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 patients 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 studys outset and its conclusion regarding their experiences and emotions related to the research
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 babys 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 patients 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 studys outset and its conclusion regarding their experiences and emotions related to the research
Detailed 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 320 weeks gestation onwards receiving regular outpatient antenatal care including routine ultrasound and CTG monitoring on the Day Assessment Unit DAU at the Birmingham Womens 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
Pregnant women from 320 weeks gestation onwards receiving regular outpatient antenatal care including routine ultrasound and CTG monitoring on the Day Assessment Unit DAU at the Birmingham Womens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None