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

Not yet recruiting

• Conditions: Fetal Distress

• Registration Number: NCT06813859
• Lead Sponsor: Balgrist University Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2024-08-09
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-10-31
• Study Completion: 2027-02-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fetal heart rate	through exercise testing, an average of 90 minutes	The fetal heart rate is continuously monitored via the CTG device during the entire performance test.

Secondary Outcome Measures

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