Remote Telemedicine Fetal Monitoring Feasibility Study

NCT06366711 | Completed

• 1 other identifier: 23/BW/MAT/NO/754
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring.

  Ultrasound scans will be assessed upon the criterion that the device is currently licensed for: fetal movements, fetal heartbeat and an objective assessment of the liquor volume.

  Through study completion, an average of 6 months

• The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring.

  Completion of an at least 20 minutes of uninterrupted interpretable fetal heart recording which has computerised capability.

  Through study completion, an average of 6 months

Secondary Outcomes (8)

• The number of participants completing the full schedule of home maternal-fetal monitoring episodes.

  Through study completion, an average of 6 months

• To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home?

  6 months

• The number of women approached who agreed to participate within the study.

  Pre-intervention

• What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring.

  Pre-intervention

• What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring.

  Immediately after the intervention

Study Arms (3)

Home antenatal CTG monitoring

EXPERIMENTAL

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 monitor for at least a four-week period or until delivery.

Device: Pregnabit Pro device and PregnaOne platform

Home antenatal ultrasound monitoring

EXPERIMENTAL

Participants will be asked to use the remote monitoring devices once a fortnight, on mutually agreed days for the duration by which the scan has been completed. Ideally participants will use the home ultrasound monitor for at least a 8-week period or until delivery.

Drug: Pulsenmore device

Usage of both home antenatal ultrasound and CTG monitoring devices

EXPERIMENTAL

Follow both device plans above.

Device: Pregnabit Pro device and PregnaOne platform; Drug: Pulsenmore device

Interventions

Pregnabit Pro device and PregnaOne platform DEVICE

Remote CTG device for pregnancy care

Home antenatal CTG monitoring; Usage of both home antenatal ultrasound and CTG monitoring devices

Pulsenmore device DRUG

Remote ultrasound device for pregnancy care

Home antenatal ultrasound monitoring; Usage of both home antenatal ultrasound and CTG monitoring devices

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead
• GE Healthcare: collaborator
• Nestmedic Spolka Akcyjna: collaborator

Study Sites (1)

Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

Location

Related Publications (1)

• Le Vance J, Emms A, Hodgetts Morton V, Morris RK, Gurney L. Remote maternal-fetal telemedicine monitoring for high-risk pregnancy care: A feasibility study. PLoS One. 2025 Nov 14;20(11):e0336797. doi: 10.1371/journal.pone.0336797. eCollection 2025.

  PMID: 41237146 DERIVED

Study Officials

• Leo Gurney

  Birmingham Women's and Children's NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research fellow in maternal-fetal medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 16, 2024
• Study Start: June 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 20, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)