protocolSection identificationModule nctId: NCT06366711, orgStudyIdInfo id: 23/BW/MAT/NO/754, briefTitle: Remote Telemedicine Fetal Monitoring Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Birmingham Women's NHS Foundation Trust, class: OTHER_GOV, collaborators name: GE Healthcare, collaborators name: Nestmedic S.A., descriptionModule briefSummary: 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., conditionsModule conditions: Pregnancy, High Risk, conditions: Telemonitoring, conditions: Telemedicine, conditions: Ultrasound, conditions: Cardiotocography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Pregnabit Pro device and PregnaOne platform, interventions name: Pulsenmore device, outcomesModule primaryOutcomes measure: The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring., primaryOutcomes measure: The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring., secondaryOutcomes measure: The number of participants completing the full schedule of home maternal-fetal monitoring episodes., secondaryOutcomes measure: To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home?, secondaryOutcomes measure: The number of women approached who agreed to participate within the study., secondaryOutcomes measure: What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring., secondaryOutcomes measure: What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring., secondaryOutcomes measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring., secondaryOutcomes measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring., secondaryOutcomes 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., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False