Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
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: exercise testing.
- Кому может быть актуально
- Состояния в реестре: Fetal Distress. Базовые параметры: 18 лет — 45 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.
Подробное описание
The aim of the study is to evaluate in a preliminary step the validity of fetal heart rate measurement with the "Nemo Healthcare Monitoring System" - a wireless non-invasive CTG device. Furthermore, we will determine the reliability for CTG measurements (intraobserver and interobserver reliability) and for ultrasound (intraobserver reliability). The device is approved for use on pregnant women and is regularly used as a CTG device for monitoring fetal heart rate and contractions during childbirth. If in the preliminary step the heart rate measurements with the "Nemo Fetal Monitoring System" provide valid and fetal heart rate results compared to the standard Doppler ultrasound method and provide a reliable detection of fetal heart rate deceleration the effects of phys-ical activity on fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply rate will be investigated in the main part of the study in a larger study population.
It is hypothesized that CTG provides technically a valid and reliable continuous re-cording of fetal heart rate values, since fetal heart rate measurement under physical exertion has previously only been possible by intermittent but not continuous Dop-pler ultrasound. Furthermore, we will evaluate alterations in fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply according to the level of exertion.
Вмешательства
- Другое exercise testing
incremental cycling test on a bicycle ergometer
Первичные конечные точки
- fetal heart rate [Срок оценки: through exercise testing, an average of 90 minutes]
Вторичные конечные точки (12)
- Umbilical cord artery pulsatility index [Срок оценки: through exercise testing, an average of 90 minutes]
- Umbilical cord artery resistance index [Срок оценки: through exercise testing, an average of 90 minutes]
- umbilical cord artery S/D ratio [Срок оценки: through exercise testing, an average of 90 minutes]
- Medial cerebral artery pulsatility index [Срок оценки: through exercise testing, an average of 90 minutes]
- Medial cerebral artery resistance index [Срок оценки: through exercise testing, an average of 90 minutes]
- medial cerebral artery peak systolic velocity [Срок оценки: through exercise testing, an average of 90 minutes]
- right and left uterine artery pulsatility index [Срок оценки: through exercise testing, an average of 90 minutes]
- right and left uterine artery resistance index [Срок оценки: through exercise testing, an average of 90 minutes]
- cerebro-placental ratio [Срок оценки: through exercise testing, an average of 90 minutes]
- pregnancy complications [Срок оценки: during pregnancy and up to12 weeks after birth]
- birth complications [Срок оценки: On the day the child is born]
- mode of delivery [Срок оценки: On the day the child is born]
Критерии участия
Критерии включения
- Presence of signed informed consent form
- healthy pregnant active female over the age of 18 years and below 45 years
- sporting activity >4h/week on 2 or more weekdays
- single pregnancy, between 28+0 and 34+0 weeks of pregnancy
Критерии исключения
- No signed informed consent form or revocation of consent
- pre-existing pregnancy complications
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 2 центра
- Balgrist University Hospital — Zurich
- University Hospital Zurich — Zurich
Идентификаторы
NCT: NCT06813859 · 2023-01380