PregnancyNIEM-SNCT07077109
Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise
A study testing Electrophysiological monitoring in people with Pregnancy and Monitoring, run by Maxima Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Monitoring
- What is being tested?
- Electrophysiological monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study
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.
Read the detailed description
The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.
- Conditions
- Pregnancy, Monitoring
- Being tested
- Electrophysiological monitoring
- Keywords
- Electrophysiological monitoring, Pregnancy, Sport, Feasibility study, Maternal exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiological monitoring | Experimental | See intervention Receives: Device: Electrophysiological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of continuous electrophysiolgoical monitoring during 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%
Measured: 15 minutes (min) before, 30 min during and 15 min after maternal exercise
Secondary outcomes (12)
Maternal heartrate
Mean maternal heart rate in beats per minutes (bpm) from cardiotocogram
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Mean maternal heartrate
Mean maternal heart rate in bpm from cardiotocographic output
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Fetal heart rate variability
Fetal heart rate variability from cardiotocogram, measured as average short term variability and average long term variability
Measured: 15 min before, 30 min during, 15 min after exercise
Fetal heart rate
Mean fetal heart rate in bpm from cardiotocogram
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Contraction frequency
Mean contraction freqency from cardiotocogram, defined as the number of contractions per 10 minutes.
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Contraction duration
Mean contraction duration in seconds from cardiotocogram
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Contraction intensity
Mean maximum contraction intensity (i.e. amplitude) from cardiotocogram (in arbitrary units)
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Contraction interval
Mean contraction interval in seconds, from cardiotocogram
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Accelerations
Increase in the fetal heart rate above the baseline lasting 10-120 seconds and reaching a peak of at least 10 seconds, from cardiotocogram
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Decelerations
Decrease in fetal heart rate under the baseline lasting at 15 seconds, and with a minimum amplitude of 15 seconds, from cardiotocogram.
Measured: 15 min before, 30 min during and 15 min after maternal exercise
Signal loss
Percentage of fetal heart rate signals values under 35bpm, from cardiotocogram
Measured: 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
Maternal satisfaction by selfmade questionnaire
Measured: Directly after exercise (duration to complete: 10 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Oct 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion13 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phebe Berben, Maxima Medical Center
- Investigators
- Simone Goossens, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077109
- Sponsor's protocol ID
- NL009785
- Acronym
- NIEM-S
- Status last verified
- Jul 2025
- First submitted
- 22 Apr 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07077109
- Acronym / sponsor ID
- NIEM-S / NL009785
- Conditions
- Pregnancy, Monitoring
- Keywords
- Electrophysiological monitoring, Pregnancy, Sport, Feasibility study, Maternal exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 13 Mar 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrophysiological monitoring | Experimental | Device: Electrophysiological monitoringSee intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological monitoringelectrofysiological 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. | Device | Electrophysiological monitoring |
Primary outcome
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%
12 secondary outcomes
Maternal heartrate
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Mean maternal heartrate
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Fetal heart rate variability
Time frame: 15 min before, 30 min during, 15 min after exercise
Fetal heart rate
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Contraction frequency
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Contraction duration
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Contraction intensity
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Contraction interval
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Accelerations
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Decelerations
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Signal loss
Time frame: 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
Time frame: Directly after exercise (duration to complete: 10 min)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone Goossens, PhD principal investigator
Principal Investigator
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological monitoring in people with Pregnancy and Monitoring, run by Maxima Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phebe Berben, Medical Doctor, PhD Candidate (+3140 - 888 80, phebe.berben@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of continuous electrophysiolgoical monitoring during maternal exercise (time frame: 15 minutes (min) before, 30 min during and 15 min after maternal exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.