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Набор скоро начнётся NCT07077109

Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise

Без фазы С лечением Pregnancy Monitoring

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: Electrophysiological monitoring.
Кому может быть актуально
Состояния в реестре: Pregnancy, Monitoring. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study

Обзор

This feasibility study will be the first study to assess the feasibility of continuous electrophysiological monitoring during maternal exercise in women with an uncomplicated pregnancy. This may help to better understand fetal condition during exercise and offer personalised exercise recommendations in the future. In future, validating the feasibility and safety of exercise could promote greater exercise engagement among pregnant women and increase fetal wellbeiing.

Подробное описание

The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.

Вмешательства

  • Устройство Electrophysiological monitoring
    electrofysiological CTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands). The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography.

Первичные конечные точки

  • Success rate of continuous electrophysiolgoical monitoring during maternal exercise [Срок оценки: 15 minutes (min) before, 30 min during and 15 min after maternal exercise]
Вторичные конечные точки (12)
  • Maternal heartrate [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Mean maternal heartrate [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Fetal heart rate variability [Срок оценки: 15 min before, 30 min during, 15 min after exercise]
  • Fetal heart rate [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Contraction frequency [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Contraction duration [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Contraction intensity [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Contraction interval [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Accelerations [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Decelerations [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Signal loss [Срок оценки: 15 min before, 30 min during and 15 min after maternal exercise]
  • Maternal satisfaction of continuous fetal monitoring and tolerability of the patch during exercise [Срок оценки: Directly after exercise (duration to complete: 10 min)]

Критерии участия

Критерии включения

  • Minimal age of 18 years old
  • Pregnant women with an uncomplicated singleton pregnancy and a gestational age between 30+0 and 40+0 weeks and days
  • Oral and written informed consent is obtained
  • Engage in aerobic exercise during pregnancy

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Insufficient knowledge of Dutch or English language
  • Women with a multiple pregnancy
  • Contra-indications for the Nemo Fetal Monitoring System (NFMS):
  • Fetal and/or maternal cardiac arrhythmias
  • Contraindications to abdominal placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
  • Women connected to an external or implanted electrical stimulator, such as a pacemaker (because of disturbance of the electrophysiological signal)
  • Fetus with known congenital or chromosomal abnormalities
  • Women with absolute or relative contraindications to aerobic exercise during pregnancy at time of inclusions and during maternal exercise:
  • Mild or severe respiratory diseases (e.g. chronic obstructive pulmonary disease, restrictive lung disease and cystic fibrosis)
  • Mild or severe acquired or congenital heart disease with exercise intolerance
  • Uncontrolled or severe arrhythmia
  • Vasa previa
  • Type 1 diabetes
  • IUGR
  • Severe PE
  • Cervical insufficiency
  • Women with relative contraindications to aerobic exercise during pregnancy:
  • Mild respiratory disorders
  • Mild congenital or acquired heart disease
  • Well-controlled type 1 diabetes
  • Pre-eclampsia
  • Cervical insufficiency
  • Placenta previa
  • Untreated thyroid disease
  • Symptomatic, severe eating disorder
  • Multiple nutrient deficiencies and/or chronic undernutrition
  • Moderate-heavy smoking (> 20 cigarettes per day)

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
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07077109 · NL009785

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗