Fetal DistressNCT06813859
Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
An observational study of Fetal Distress, run by Balgrist University Hospital at 2 sites in Switzerland.
Trial summary
Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress
- What is being tested?
- exercise testing
- How many people
- 20 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 30 Jun 2025to 27 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant athletes
Who may be able to join
- 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
Who cannot join
- No signed informed consent form or revocation of consent
- pre-existing pregnancy complications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Nora Wieloch, KD Dr. med., +41 44 386 11 11, nora.wieloch@balgrist.ch
Nora Wieloch, KD Dr. med.
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Kimmich Nina, PD Dr. med., +41 44 255 1111, nina.kimmich@usz.ch
Nina Kimmich, PD Dr. med.
About this study
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.
- Conditions
- Fetal Distress
- Being tested
- exercise testing
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise testingOther
incremental cycling test on a bicycle ergometer
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal heart rate
The fetal heart rate is continuously monitored via the CTG device during the entire performance test.
Measured: through exercise testing, an average of 90 minutes
Secondary outcomes (16)
Umbilical cord artery pulsatility index
(systolic velocity - diastolic velocity) / mean velocity
Measured: through exercise testing, an average of 90 minutes
Umbilical cord artery resistance index
(systolic velocity - diastolic velocity) / systolic velocity
Measured: through exercise testing, an average of 90 minutes
umbilical cord artery S/D ratio
(S = maximum systolic flow velocity; D = maximum diastolic flow velocity)
Measured: through exercise testing, an average of 90 minutes
Medial cerebral artery pulsatility index
(systolic velocity - diastolic velocity) / mean velocity
Measured: through exercise testing, an average of 90 minutes
Medial cerebral artery resistance index
(systolic velocity - diastolic velocity) / systolic velocity
Measured: through exercise testing, an average of 90 minutes
medial cerebral artery peak systolic velocity
in cm/s
Measured: through exercise testing, an average of 90 minutes
right and left uterine artery pulsatility index
(systolic velocity - diastolic velocity) / mean velocity
Measured: through exercise testing, an average of 90 minutes
right and left uterine artery resistance index
(systolic velocity - diastolic velocity) / systolic velocity
Measured: through exercise testing, an average of 90 minutes
cerebro-placental ratio
pulsatility index of the middle cerebral artery / pulsatility index of the umbilical artery
Measured: through exercise testing, an average of 90 minutes
pregnancy complications
incidence of pregnancy complications (yes/no);
Measured: during pregnancy and up to12 weeks after birth
birth complications
incidence of birth complications (yes/no);
Measured: On the day the child is born
mode of delivery
spontaneous birth vs. vacuum-assisted birth vs. forceps-assisted birth vs planned cesarean section vs. unplanned cesarean section
Measured: On the day the child is born
APGAR score
APGAR score (1-10)
Measured: On the day the child is born
gestational age at birth
gestational age at birth (in weeks and days);
Measured: On the day the child is born
pH value of the umbilical cord artery
pH value of the umbilical cord artery mesured directly after birth
Measured: On the day the child is born
fetal admission to Neonatal Intensive Care Unit
admission (yes/no)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start30 Jun 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813859
- Sponsor's protocol ID
- 2023-01380
- Other IDs
- 2023
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device
- ClinicalTrials.gov ID
- NCT06813859
- Acronym / sponsor ID
- 2023-01380
- Conditions
- Fetal Distress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant athletes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No signed informed consent form or revocation of consent
- pre-existing pregnancy complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise testingincremental cycling test on a bicycle ergometer | Other | – |
Primary outcome
fetal heart rate
Time frame: through exercise testing, an average of 90 minutes
The fetal heart rate is continuously monitored via the CTG device during the entire performance test.
16 secondary outcomes
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
APGAR score
Time frame: On the day the child is born
gestational age at birth
Time frame: On the day the child is born
pH value of the umbilical cord artery
Time frame: On the day the child is born
fetal admission to Neonatal Intensive Care Unit
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Fetal Distress
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Recruiting
The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
Fetal Health Anxiety, Prenatal Distress
Recruiting
Maternal Oxygen Supplementation for Intrauterine Resuscitation
Fetal Distress, Fetal Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Distress, run by Balgrist University Hospital at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Wieloch, Dr. med. (0041443861111, nora.wieloch@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal heart rate (time frame: through exercise testing, an average of 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.