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Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07077109
Acronym
NIEM-S
Enrollment
15
Registered
2025-07-22
Start date
2025-10-15
Completion date
2026-03-13
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monitoring, Pregnancy

Keywords

Electrophysiological monitoring, Pregnancy, Sport, Feasibility study, Maternal exercise

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.

Interventions

DEVICEElectrophysiological 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.

Sponsors

Maxima Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Success rate of continuous electrophysiolgoical monitoring during maternal exercise15 minutes (min) before, 30 min during and 15 min after maternal exerciseDefined 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

MeasureTime frameDescription
Mean maternal heartrate15 min before, 30 min during and 15 min after maternal exerciseMean maternal heart rate in bpm from cardiotocographic output
Fetal heart rate variability15 min before, 30 min during, 15 min after exerciseFetal heart rate variability from cardiotocogram, measured as average short term variability and average long term variability
Fetal heart rate15 min before, 30 min during and 15 min after maternal exerciseMean fetal heart rate in bpm from cardiotocogram
Contraction frequency15 min before, 30 min during and 15 min after maternal exerciseMean contraction freqency from cardiotocogram, defined as the number of contractions per 10 minutes.
Contraction duration15 min before, 30 min during and 15 min after maternal exerciseMean contraction duration in seconds from cardiotocogram
Maternal heartrate15 min before, 30 min during and 15 min after maternal exerciseMean maternal heart rate in beats per minutes (bpm) from cardiotocogram
Contraction interval15 min before, 30 min during and 15 min after maternal exerciseMean contraction interval in seconds, from cardiotocogram
Accelerations15 min before, 30 min during and 15 min after maternal exerciseIncrease in the fetal heart rate above the baseline lasting 10-120 seconds and reaching a peak of at least 10 seconds, from cardiotocogram
Decelerations15 min before, 30 min during and 15 min after maternal exerciseDecrease in fetal heart rate under the baseline lasting at 15 seconds, and with a minimum amplitude of 15 seconds, from cardiotocogram.
Signal loss15 min before, 30 min during and 15 min after maternal exercisePercentage of fetal heart rate signals values under 35bpm, from cardiotocogram
Maternal satisfaction of continuous fetal monitoring and tolerability of the patch during exerciseDirectly after exercise (duration to complete: 10 min)Maternal satisfaction by selfmade questionnaire
Contraction intensity15 min before, 30 min during and 15 min after maternal exerciseMean maximum contraction intensity (i.e. amplitude) from cardiotocogram (in arbitrary units)

Contacts

Primary ContactPhebe Berben, Medical Doctor, PhD Candidate
phebe.berben@mmc.nl+3140 - 888 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026