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NCT Number: NCT06813859

Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device

Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.

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Key information

Conditions

Fetal Distress Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Balgrist University Hospital, Zurich, Canton of Zurich, Switzerland

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About this study

The aim of the study is to evaluate in a preliminary step the validity of fetal heart rate measurement with the "Nemo Healthcare Monitoring System" - a wireless non-invasive CTG device. Furthermore, we will determine the reliability for CTG measurements (intraobserver and interobserver reliability) and for ultrasound (intraobserver reliability). The device is approved for use on pregnant women and is regularly used as a CTG device for monitoring fetal heart rate and contractions during childbirth. If in the preliminary step the heart rate measurements with the "Nemo Fetal Monitoring System" provide valid and fetal heart rate results compared to the standard Doppler ultrasound method and provide a reliable detection of fetal heart rate deceleration the effects of phys-ical activity on fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply rate will be investigated in the main part of the study in a larger study population.

It is hypothesized that CTG provides technically a valid and reliable continuous re-cording of fetal heart rate values, since fetal heart rate measurement under physical exertion has previously only been possible by intermittent but not continuous Dop-pler ultrasound. Furthermore, we will evaluate alterations in fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply according to the level of exertion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Presence of signed informed consent form
  • healthy pregnant active female over the age of 18 years and below 45 years
  • sporting activity >4h/week on 2 or more weekdays
  • single pregnancy, between 28+0 and 34+0 weeks of pregnancy

Exclusion criteria

  • No signed informed consent form or revocation of consent
  • pre-existing pregnancy complications

Treatment and study plan

exercise testing

Other

incremental cycling test on a bicycle ergometer

Primary outcomes

  1. fetal heart rate

    Time frame: through exercise testing, an average of 90 minutes

    The fetal heart rate is continuously monitored via the CTG device during the entire performance test.

Secondary outcomes

  1. Umbilical cord artery pulsatility index

    Time frame: through exercise testing, an average of 90 minutes

    (systolic velocity - diastolic velocity) / mean velocity

  2. Umbilical cord artery resistance index

    Time frame: through exercise testing, an average of 90 minutes

    (systolic velocity - diastolic velocity) / systolic velocity

  3. umbilical cord artery S/D ratio

    Time frame: through exercise testing, an average of 90 minutes

    (S = maximum systolic flow velocity; D = maximum diastolic flow velocity)

  4. Medial cerebral artery pulsatility index

    Time frame: through exercise testing, an average of 90 minutes

    (systolic velocity - diastolic velocity) / mean velocity

  5. Medial cerebral artery resistance index

    Time frame: through exercise testing, an average of 90 minutes

    (systolic velocity - diastolic velocity) / systolic velocity

  6. medial cerebral artery peak systolic velocity

    Time frame: through exercise testing, an average of 90 minutes

    in cm/s

  7. right and left uterine artery pulsatility index

    Time frame: through exercise testing, an average of 90 minutes

    (systolic velocity - diastolic velocity) / mean velocity

  8. right and left uterine artery resistance index

    Time frame: through exercise testing, an average of 90 minutes

    (systolic velocity - diastolic velocity) / systolic velocity

  9. cerebro-placental ratio

    Time frame: through exercise testing, an average of 90 minutes

    pulsatility index of the middle cerebral artery / pulsatility index of the umbilical artery

  10. pregnancy complications

    Time frame: during pregnancy and up to12 weeks after birth

    incidence of pregnancy complications (yes/no);

  11. birth complications

    Time frame: On the day the child is born

    incidence of birth complications (yes/no);

  12. mode of delivery

    Time frame: On the day the child is born

    spontaneous birth vs. vacuum-assisted birth vs. forceps-assisted birth vs planned cesarean section vs. unplanned cesarean section

  13. APGAR score

    Time frame: On the day the child is born

    APGAR score (1-10)

  14. gestational age at birth

    Time frame: On the day the child is born

    gestational age at birth (in weeks and days);

  15. pH value of the umbilical cord artery

    Time frame: On the day the child is born

    pH value of the umbilical cord artery mesured directly after birth

  16. fetal admission to Neonatal Intensive Care Unit

    Time frame: up to 12 weeks

    admission (yes/no)

Study contacts

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

Nina Kimmich, PD Dr. med.

CONTACT

[email protected]

0041442551111

Nora Wieloch, Dr. med.

CONTACT

[email protected]

0041443861111

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • University Hospital, Zürich

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Jul 9, 2026

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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