Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMaxima Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Electrophysiological monitoring
Deviceelectrofysiological 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Electrophysiological monitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 exerciseSecondary outcomes
1
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 exercise2
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 exercise3
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 exercise4
Fetal heart rate
Mean fetal heart rate in bpm from cardiotocogram
Time frame
15 min before, 30 min during and 15 min after maternal exerciseLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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