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

B

Balgrist University Hospital

Status

Not yet enrolling

Conditions

Fetal Distress

Treatments

Other: exercise testing

Study type

Observational

Funder types

Other

Identifiers

NCT06813859
2023-01380

Details and patient eligibility

About

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

Full description

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.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Nina Kimmich, PD Dr. med.; Nora Wieloch, Dr. med.

Data sourced from clinicaltrials.gov

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