An interventional study of Electrophysiological monitoring in Pregnancy and Monitoring, sponsored by Maxima Medical Center. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Maxima Medical Center · Not applicable, Interventional, and Supportive care
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.
The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.
Inclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Contra-indications for the Nemo Fetal Monitoring System (NFMS):
Women with absolute or relative contraindications to aerobic exercise during pregnancy at time of inclusions and during maternal exercise:
Women with relative contraindications to aerobic exercise during pregnancy:
See intervention
Device: Electrophysiological 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.
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%
Time frame: 15 minutes (min) before, 30 min during and 15 min after maternal exercise
Maternal heartrate
Mean maternal heart rate in beats per minutes (bpm) from cardiotocogram
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Mean maternal heartrate
Mean maternal heart rate in bpm from cardiotocographic output
Time frame: 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
Time frame: 15 min before, 30 min during, 15 min after exercise
Fetal heart rate
Mean fetal heart rate in bpm from cardiotocogram
Time frame: 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.
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Contraction duration
Mean contraction duration in seconds from cardiotocogram
Time frame: 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)
Time frame: 15 min before, 30 min during and 15 min after maternal exercise
Contraction interval
Mean contraction interval in seconds, from cardiotocogram
Time frame: 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
Time frame: 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.
Time frame: 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
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
Maternal satisfaction by selfmade questionnaire
Time frame: Directly after exercise (duration to complete: 10 min)
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Maxima Medical Center