Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exercise testing.
- Who it may be relevant to
- Registry conditions: Fetal Distress. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.
Detailed 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.
Interventions
- Other exercise testing
incremental cycling test on a bicycle ergometer
Primary outcome measures
- fetal heart rate [Time frame: through exercise testing, an average of 90 minutes]
Secondary outcome measures (12)
- Umbilical cord artery pulsatility index [Time frame: through exercise testing, an average of 90 minutes]
- Umbilical cord artery resistance index [Time frame: through exercise testing, an average of 90 minutes]
- umbilical cord artery S/D ratio [Time frame: through exercise testing, an average of 90 minutes]
- Medial cerebral artery pulsatility index [Time frame: through exercise testing, an average of 90 minutes]
- Medial cerebral artery resistance index [Time frame: through exercise testing, an average of 90 minutes]
- medial cerebral artery peak systolic velocity [Time frame: through exercise testing, an average of 90 minutes]
- right and left uterine artery pulsatility index [Time frame: through exercise testing, an average of 90 minutes]
- right and left uterine artery resistance index [Time frame: through exercise testing, an average of 90 minutes]
- cerebro-placental ratio [Time frame: through exercise testing, an average of 90 minutes]
- pregnancy complications [Time frame: during pregnancy and up to12 weeks after birth]
- birth complications [Time frame: On the day the child is born]
- mode of delivery [Time frame: On the day the child is born]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 2 centers
- Balgrist University Hospital — Zurich
- University Hospital Zurich — Zurich
Identifiers
NCT: NCT06813859 · 2023-01380