ClinicalTrials.gg
RecruitingNCT06813859Updated Jul 9, 2026

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

An observational study in Fetal Distress, sponsored by Balgrist University Hospital. Recruiting at 2 sites in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Balgrist University Hospital · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Fetal Distress

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03

In context

Fetal Distress

37 studies on the registry are indexed under Fetal Distress; 7 are open to participants now.

This study's planned enrollment of 20 is below the median of 121 across 12 observational studies indexed under Fetal Distress.

Browse Fetal Distress studies →

Lead sponsor

Balgrist University Hospital is the lead sponsor of 81 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

pregnant athletes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presence of signed 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

Exclusion Criteria:

  • No signed form or revocation of consent
  • pre-existing pregnancy complications
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • Otherexercise testing

    incremental cycling test on a bicycle ergometer

06

What researchers measure

Primary outcomes

  1. fetal heart rate

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

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

Secondary outcomes

  1. Umbilical cord artery pulsatility index

    (systolic velocity - diastolic velocity) / mean velocity

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

  2. Umbilical cord artery resistance index

    (systolic velocity - diastolic velocity) / systolic velocity

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

  3. umbilical cord artery S/D ratio

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

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

  4. Medial cerebral artery pulsatility index

    (systolic velocity - diastolic velocity) / mean velocity

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

  5. Medial cerebral artery resistance index

    (systolic velocity - diastolic velocity) / systolic velocity

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

  6. medial cerebral artery peak systolic velocity

    in cm/s

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

  7. right and left uterine artery pulsatility index

    (systolic velocity - diastolic velocity) / mean velocity

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

  8. right and left uterine artery resistance index

    (systolic velocity - diastolic velocity) / systolic velocity

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

  9. cerebro-placental ratio

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

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

  10. pregnancy complications

    incidence of pregnancy complications (yes/no);

    Time frame: during pregnancy and up to12 weeks after birth

  11. birth complications

    incidence of birth complications (yes/no);

    Time frame: On the day the child is born

  12. mode of delivery

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

    Time frame: On the day the child is born

  13. APGAR score

    APGAR score (1-10)

    Time frame: On the day the child is born

  14. gestational age at birth

    gestational age at birth (in weeks and days);

    Time frame: On the day the child is born

  15. pH value of the umbilical cord artery

    pH value of the umbilical cord artery mesured directly after birth

    Time frame: On the day the child is born

  16. fetal admission to Neonatal Intensive Care Unit

    admission (yes/no)

    Time frame: up to 12 weeks

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Oct 2026, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2024
First posted
Feb 7, 2025
StartActual
Jun 30, 2025
Primary completionEst.
Oct 31, 2026
CompletionEst.
Feb 27, 2027
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06813859
Lead sponsor
Balgrist University Hospital
Collaborators
University Hospital, Zürich
Responsible party
Sponsor
First posted
Feb 7, 2025
Start date
Jun 30, 2025
Primary completion
Oct 31, 2026 (estimated)
Completion
Feb 27, 2027 (estimated)
Last update
Jul 9, 2026

Study contacts

Nora Wieloch, Dr. med.
Contact
nora.wieloch@balgrist.ch
0041443861111
Nina Kimmich, PD Dr. med.
Contact
nina.kimmich@usz.ch
0041442551111
Johannes Scherr, Prof. Dr. med.
study chair · University Centre for Prevention and Sports Medicine, Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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