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

NCT06813859 | Not Yet Recruiting

• 1 other identifier: 2023-01380
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

• fetal heart rate

  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 Outcomes (16)

• Umbilical cord artery pulsatility index

  through exercise testing, an average of 90 minutes

• Umbilical cord artery resistance index

  through exercise testing, an average of 90 minutes

• umbilical cord artery S/D ratio

  through exercise testing, an average of 90 minutes

• Medial cerebral artery pulsatility index

  through exercise testing, an average of 90 minutes

• Medial cerebral artery resistance index

  through exercise testing, an average of 90 minutes

Interventions

exercise testing OTHER

incremental cycling test on a bicycle ergometer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant athletes

You may qualify if:

• 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

You may not qualify if:

• No signed informed consent form or revocation of consent
• pre-existing pregnancy complications

Sponsors & Collaborators

• Balgrist University Hospital: lead
• University Hospital, Zürich: collaborator

MeSH Terms

Conditions

Fetal Distress

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Johannes Scherr, Prof. Dr. med.

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

  STUDY CHAIR

Central Study Contacts

Nora Wieloch, Dr. med.

CONTACT

0041443861111; nora.wieloch@balgrist.ch

Nina Kimmich, PD Dr. med.

CONTACT

0041442551111; nina.kimmich@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: February 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 27, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share