NCT07077109Not yet recruitingNot Applicable
Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study
Maxima Medical Center0 sites15 target enrollmentStarted: October 15, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Primary Endpoint
- Success rate of continuous electrophysiolgoical monitoring during maternal exercise
Study Overview
Brief Summary
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.
Detailed Description
The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- Not provided
Arms & Interventions
Electrophysiological monitoring
Experimental
See intervention
Intervention: Electrophysiological monitoring (Device)
Outcomes
Primary Outcomes
Success rate of continuous electrophysiolgoical monitoring during maternal exercise
Time Frame: 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%
Secondary Outcomes
- 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)
Investigators
Phebe Berben
Medical doctor, PhD Candidate, Coordinating Investigator NIEM-S study
Maxima Medical Center
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