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

NCT ID: NCT06813859

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-02-27

Brief Summary

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

Detailed Description

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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

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Fetal Distress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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exercise testing

incremental cycling test on a bicycle ergometer

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

Balgrist University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johannes Scherr, Prof. Dr. med.

Role: STUDY_CHAIR

University Centre for Prevention and Sports Medicine, Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland

Central Contacts

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Nora Wieloch, Dr. med.

Role: CONTACT

0041443861111

Nina Kimmich, PD Dr. med.

Role: CONTACT

0041442551111

Other Identifiers

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2023-01380

Identifier Type: -

Identifier Source: org_study_id

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