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

February 4, 2025 updated by: Balgrist University Hospital
Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

pregnant athletes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through exercise testing, an average of 90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical cord artery pulsatility index
Time Frame: through exercise testing, an average of 90 minutes
(systolic velocity - diastolic velocity) / mean velocity
through exercise testing, an average of 90 minutes
Umbilical cord artery resistance index
Time Frame: through exercise testing, an average of 90 minutes
(systolic velocity - diastolic velocity) / systolic velocity
through exercise testing, an average of 90 minutes
umbilical cord artery S/D ratio
Time Frame: through exercise testing, an average of 90 minutes
(S = maximum systolic flow velocity; D = maximum diastolic flow velocity)
through exercise testing, an average of 90 minutes
Medial cerebral artery pulsatility index
Time Frame: through exercise testing, an average of 90 minutes
(systolic velocity - diastolic velocity) / mean velocity
through exercise testing, an average of 90 minutes
Medial cerebral artery resistance index
Time Frame: through exercise testing, an average of 90 minutes
(systolic velocity - diastolic velocity) / systolic velocity
through exercise testing, an average of 90 minutes
medial cerebral artery peak systolic velocity
Time Frame: through exercise testing, an average of 90 minutes
in cm/s
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
(systolic velocity - diastolic velocity) / mean velocity
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
(systolic velocity - diastolic velocity) / systolic velocity
through exercise testing, an average of 90 minutes
cerebro-placental ratio
Time Frame: through exercise testing, an average of 90 minutes
pulsatility index of the middle cerebral artery / pulsatility index of the umbilical artery
through exercise testing, an average of 90 minutes
pregnancy complications
Time Frame: during pregnancy and up to12 weeks after birth
incidence of pregnancy complications (yes/no);
during pregnancy and up to12 weeks after birth
birth complications
Time Frame: On the day the child is born
incidence of birth complications (yes/no);
On the day the child is born
mode of delivery
Time Frame: On the day the child is born
spontaneous birth vs. vacuum-assisted birth vs. forceps-assisted birth vs planned cesarean section vs. unplanned cesarean section
On the day the child is born
APGAR score
Time Frame: On the day the child is born
APGAR score (1-10)
On the day the child is born
gestational age at birth
Time Frame: On the day the child is born
gestational age at birth (in weeks and days);
On the day the child is born
pH value of the umbilical cord artery
Time Frame: On the day the child is born
pH value of the umbilical cord artery mesured directly after birth
On the day the child is born
fetal admission to Neonatal Intensive Care Unit
Time Frame: up to 12 weeks
admission (yes/no)
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Collaborators

University Hospital, Zürich

Investigators

  • Study Chair: Johannes Scherr, Prof. Dr. med., University Centre for Prevention and Sports Medicine, Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

February 27, 2027

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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