Clinical trial NCT06366711: Remote Telemedicine Fetal Monitoring Feasibility Study
Official title: Remote Antenatal Maternal-fetal Telemedicine Monitoring in High-risk Pregnancies: a Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Telemonitoring
Telemedicine
Ultrasound
Cardiotocography
Lead sponsor: Birmingham Women's NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: GE Healthcare
name: Nestmedic S.A.
First posted: 2024-04-16
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 15 participants split in to three arms. The sample size has been determined as a pragmatic sample taking into consideration the needs of the feasibility study to meet the stated objectives as well as being achievable within the time and cost constraints of the study. 15 participants will ensure a thorough assessment of the stated objectives.
Primary purpose: DEVICE_FEASIBILITY

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Women aged ≥18 years
* Gestational age 32+0 weeks onwards.
* Singleton pregnancy.
* Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 4 index conditions (pregnancy induced hypertension (PIH), obstetric cholestasis, PPROM and previous history of stillbirth)
* Able to give written informed consent.
* Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices.

Exclusion Criteria:

* Multiple pregnancy.
* Fetal abnormalities or a non-viable fetus.
* Body mass index (BMI) ≥35
* Women with internal cardiac devices such as pacemaker and implantable cardioverter defibrillator.
* History of allergic reaction to skin adhesives and/or latex.
* Acute or chronic skin lesions and wounds in areas in contact with the device.
* Medical or midwifery concerns regarding maternal and/or fetal conditions such that inpatient care is recommended.

Primary outcomes:
measure: The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring.
timeFrame: Through study completion, an average of 6 months
measure: The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: The number of participants completing the full schedule of home maternal-fetal monitoring episodes.
timeFrame: Through study completion, an average of 6 months
measure: To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home?
timeFrame: 6 months
measure: The number of women approached who agreed to participate within the study.
timeFrame: Pre-intervention
measure: What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring.
timeFrame: Pre-intervention
measure: What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring.
timeFrame: Immediately after the intervention
measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring.
timeFrame: Pre-intervention
measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring.
timeFrame: Immediately after the intervention
measure: The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care.
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
Study officials:
affiliation: Birmingham Women's and Children's NHS Foundation Trust
name: Leo Gurney
role: STUDY_DIRECTOR
References: