Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Success rate of continuous electrophysiolgoical monitoring during maternal exercise
研究概览
简要总结
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.
详细描述
The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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)
排除标准
- 未提供
研究组 & 干预措施
Electrophysiological monitoring
See intervention
干预措施: Electrophysiological monitoring (Device)
结局指标
主要结局
Success rate of continuous electrophysiolgoical monitoring during maternal exercise
时间窗: 15 minutes (min) before, 30 min during and 15 min after maternal exercise
Defined as the percentage of time during continuous maternal exercise with concurrent signal output of the fetal heart rate. Continous electrophysiological monitoring is feasible by a successrate of =\>80%
次要结局
- Mean maternal heartrate(15 min before, 30 min during and 15 min after maternal exercise)
- Fetal heart rate variability(15 min before, 30 min during, 15 min after exercise)
- Fetal heart rate(15 min before, 30 min during and 15 min after maternal exercise)
- Contraction frequency(15 min before, 30 min during and 15 min after maternal exercise)
- Contraction duration(15 min before, 30 min during and 15 min after maternal exercise)
- Contraction intensity(15 min before, 30 min during and 15 min after maternal exercise)
- Contraction interval(15 min before, 30 min during and 15 min after maternal exercise)
- Maternal heartrate(15 min before, 30 min during and 15 min after maternal exercise)
- Accelerations(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(Directly after exercise (duration to complete: 10 min))
- Decelerations(15 min before, 30 min during and 15 min after maternal exercise)
- Signal loss(15 min before, 30 min during and 15 min after maternal exercise)
研究者
Phebe Berben
Medical doctor, PhD Candidate, Coordinating Investigator NIEM-S study
Maxima Medical Center