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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrophysiological monitoring | Experimental | See intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiological monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 15 minutes (min) before, 30 min during and 15 min after maternal exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal heartrate | Mean maternal heart rate in beats per minutes (bpm) from cardiotocogram | 15 min before, 30 min during and 15 min after maternal exercise |
| Mean maternal heartrate | Mean maternal heart rate in bpm from cardiotocographic output |
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Inclusion Criteria:
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):
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:
Women with relative contraindications to aerobic exercise during pregnancy:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phebe Berben, Medical Doctor, PhD Candidate | Contact | +3140 - 888 80 | phebe.berben@mmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Simone Goossens, PhD | Principal Investigator | Principal Investigator |
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All IPD that underlie results in a publication
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| 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 | 15 min before, 30 min during, 15 min after exercise |
| Fetal heart rate | Mean fetal heart rate in bpm from cardiotocogram | 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. | 15 min before, 30 min during and 15 min after maternal exercise |
| Contraction duration | Mean contraction duration in seconds from cardiotocogram | 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) | 15 min before, 30 min during and 15 min after maternal exercise |
| Contraction interval | Mean contraction interval in seconds, from cardiotocogram | 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 | 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. | 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 | 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 | Directly after exercise (duration to complete: 10 min) |