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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06813859
Enrollment
20
Registered
2025-02-07
Start date
2025-02-01
Completion date
2027-02-27
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Distress

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.

Interventions

incremental cycling test on a bicycle ergometer

Sponsors

University Hospital, Zürich
CollaboratorOTHER
Balgrist University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
fetal heart ratethrough exercise testing, an average of 90 minutesThe fetal heart rate is continuously monitored via the CTG device during the entire performance test.

Secondary

MeasureTime frameDescription
Medial cerebral artery pulsatility indexthrough exercise testing, an average of 90 minutes(systolic velocity - diastolic velocity) / mean velocity
Medial cerebral artery resistance indexthrough exercise testing, an average of 90 minutes(systolic velocity - diastolic velocity) / systolic velocity
medial cerebral artery peak systolic velocitythrough exercise testing, an average of 90 minutesin cm/s
Umbilical cord artery pulsatility indexthrough exercise testing, an average of 90 minutes(systolic velocity - diastolic velocity) / mean velocity
Umbilical cord artery resistance indexthrough exercise testing, an average of 90 minutes(systolic velocity - diastolic velocity) / systolic velocity
right and left uterine artery pulsatility indexthrough exercise testing, an average of 90 minutes(systolic velocity - diastolic velocity) / mean velocity
right and left uterine artery resistance indexthrough exercise testing, an average of 90 minutes(systolic velocity - diastolic velocity) / systolic velocity
umbilical cord artery S/D ratiothrough exercise testing, an average of 90 minutes(S = maximum systolic flow velocity; D = maximum diastolic flow velocity)
pregnancy complicationsduring pregnancy and up to12 weeks after birthincidence of pregnancy complications (yes/no);
birth complicationsOn the day the child is bornincidence of birth complications (yes/no);
mode of deliveryOn the day the child is bornspontaneous birth vs. vacuum-assisted birth vs. forceps-assisted birth vs planned cesarean section vs. unplanned cesarean section
APGAR scoreOn the day the child is bornAPGAR score (1-10)
gestational age at birthOn the day the child is borngestational age at birth (in weeks and days);
pH value of the umbilical cord arteryOn the day the child is bornpH value of the umbilical cord artery mesured directly after birth
fetal admission to Neonatal Intensive Care Unitup to 12 weeksadmission (yes/no)
cerebro-placental ratiothrough exercise testing, an average of 90 minutespulsatility index of the middle cerebral artery / pulsatility index of the umbilical artery

Contacts

Primary ContactNora Wieloch, Dr. med.
nora.wieloch@balgrist.ch0041443861111
Backup ContactNina Kimmich, PD Dr. med.
nina.kimmich@usz.ch0041442551111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026