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Идёт набор NCT07124325

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

Без фазы С лечением Pregnancy High Risk Telemonitoring Telemedicine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pregnabit Pro device and PregnaOne platform.
Кому может быть актуально
Состояния в реестре: Pregnancy, High Risk, Telemonitoring, Telemedicine. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.

Обзор

The overall 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 both pregnant women and HCPs. 50 women from a single site will be recruited to use a home cardiotocography (CTG) device alongside routine antenatal care. Participants will use this device once a week, for an hour at a time, for up to 6 weeks or until delivery. The primary outcome is 20 minutes of continuous monitoring. Additional outcomes assess acceptability, adherence and safety.

Вмешательства

  • Устройство Pregnabit Pro device and PregnaOne platform
    Remote CTG device and online dashboard for remote pregnancy care

Первичные конечные точки

  • The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring. [Срок оценки: Through study completion, an average of 9 months]
Вторичные конечные точки (12)
  • The number of participants completing the full schedule of home maternal-fetal monitoring episodes. [Срок оценки: Through study completion, an average of 9 months]
  • The number of women approached who agreed to participate within the study. [Срок оценки: Pre-intervention]
  • What are the emotions of participants using home maternal-fetal monitoring. [Срок оценки: Pre-intervention]
  • What are the emotions of participants using home maternal-fetal monitoring and is there an impact before and after a singular monitoring episode? [Срок оценки: Through study completion, an average of 9 months]
  • What are the emotions of participants using home maternal-fetal monitoring and was there any change from the beginning of the study. [Срок оценки: Immediately after the intervention]
  • The usability of the remote monitoring device. [Срок оценки: Immediately after the end of the intervention]
  • 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. [Срок оценки: Through study completion, an average of 9 months]
  • What are the views of participants regarding acceptability of home maternal-fetal monitoring. [Срок оценки: Pre-intervention]
  • What are the views of participants regarding acceptability of home maternal-fetal monitoring. [Срок оценки: Immediately after the intervention]
  • The influence of participant demographics on achieving the primary outcome. [Срок оценки: Through study completion, an average of 9 months]
  • Determining participant adherence to commencing the monitoring episodes [Срок оценки: Through study completion, an average of 9 months]
  • The influence of fetal movements on achieving the primary outcome [Срок оценки: Through study completion, an average of 9 months]

Критерии участия

Критерии включения

  • Women aged ≥18 years
  • Gestational age 32+0 weeks onwards.
  • Singleton pregnancy.
  • Able to speak English
  • Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 6 index conditions (hypertensive disease in pregnancy, reduced fetal growth (small for gestational age and fetal growth restriction) obstetric cholestasis, PPROM, previous history of stillbirth and recurrent reduced fetal movements )
  • Able to give written informed consent.
  • Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • Birmingham Women's and Children's NHS Foundation Trust — Birmingham

Идентификаторы

NCT: NCT07124325 · 27-6-194

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗