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NCT Number: NCT07077109

Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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%

Secondary outcomes

  1. Maternal heartrate

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean maternal heart rate in beats per minutes (bpm) from cardiotocogram

  2. Mean maternal heartrate

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean maternal heart rate in bpm from cardiotocographic output

  3. Fetal heart rate variability

    Time frame: 15 min before, 30 min during, 15 min after exercise

    Fetal heart rate variability from cardiotocogram, measured as average short term variability and average long term variability

  4. Fetal heart rate

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean fetal heart rate in bpm from cardiotocogram

  5. Contraction frequency

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean contraction freqency from cardiotocogram, defined as the number of contractions per 10 minutes.

  6. Contraction duration

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean contraction duration in seconds from cardiotocogram

  7. Contraction intensity

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean maximum contraction intensity (i.e. amplitude) from cardiotocogram (in arbitrary units)

  8. Contraction interval

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Mean contraction interval in seconds, from cardiotocogram

  9. Accelerations

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Increase in the fetal heart rate above the baseline lasting 10-120 seconds and reaching a peak of at least 10 seconds, from cardiotocogram

  10. Decelerations

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Decrease in fetal heart rate under the baseline lasting at 15 seconds, and with a minimum amplitude of 15 seconds, from cardiotocogram.

  11. Signal loss

    Time frame: 15 min before, 30 min during and 15 min after maternal exercise

    Percentage of fetal heart rate signals values under 35bpm, from cardiotocogram

  12. Maternal satisfaction of continuous fetal monitoring and tolerability of the patch during exercise

    Time frame: Directly after exercise (duration to complete: 10 min)

    Maternal satisfaction by selfmade questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Phebe Berben, Medical Doctor, PhD Candidate

CONTACT

[email protected]

+3140 - 888 80

Sponsors and collaborators

Lead sponsor

Maxima Medical Center

Other

Registry information

Official study title

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

Acronym: NIEM-S

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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