Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise
15 participantsStarted 2025-10-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* IUGR
* Severe PE
* Cervical insufficiency
* Women with relative contraindications to aerobic exercise during pregnancy:
* Mild resp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success rate of continuous electrophysiolgoical monitoring during maternal exercise
Timeframe: 15 minutes (min) before, 30 min during and 15 min after maternal exercise