Clinical trial NCT06813859: Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
Official title: Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fetal Distress
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2025-02-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant athletes

Brief summary: 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.

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

Primary outcomes:
measure: fetal heart rate
timeFrame: through exercise testing, an average of 90 minutes
Secondary outcomes:
measure: Umbilical cord artery pulsatility index
timeFrame: through exercise testing, an average of 90 minutes
measure: Umbilical cord artery resistance index
timeFrame: through exercise testing, an average of 90 minutes
measure: umbilical cord artery S/D ratio
timeFrame: through exercise testing, an average of 90 minutes
measure: Medial cerebral artery pulsatility index
timeFrame: through exercise testing, an average of 90 minutes
measure: Medial cerebral artery resistance index
timeFrame: through exercise testing, an average of 90 minutes
measure: medial cerebral artery peak systolic velocity
timeFrame: through exercise testing, an average of 90 minutes
measure: right and left uterine artery pulsatility index
timeFrame: through exercise testing, an average of 90 minutes
measure: right and left uterine artery resistance index
timeFrame: through exercise testing, an average of 90 minutes
measure: cerebro-placental ratio
timeFrame: through exercise testing, an average of 90 minutes
measure: pregnancy complications
timeFrame: during pregnancy and up to12 weeks after birth
measure: birth complications
timeFrame: On the day the child is born
measure: mode of delivery
timeFrame: On the day the child is born
measure: APGAR score
timeFrame: On the day the child is born
measure: gestational age at birth
timeFrame: On the day the child is born
measure: pH value of the umbilical cord artery
timeFrame: On the day the child is born
measure: fetal admission to Neonatal Intensive Care Unit
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Centre for Prevention and Sports Medicine, Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland
name: Johannes Scherr, Prof. Dr. med.
role: STUDY_CHAIR
References: