Intrapartum non-invasive electrophysiological monitoring: F2-study.
Recruiting
- Conditions
- non-invasive fetal ECGfetal monitoringlabourniet-invasief foetaal ECGfoetale monitoringbevalling
- Registration Number
- NL-OMON24697
- Lead Sponsor
- Maxima Medical Center, VeldhovenThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Pregnant women who are in labour, carrying a healthy, singleton fetus in cephalic presentation, with a gestational
age between 37 and 42 weeks
Exclusion Criteria
- < 18 years of age
- Multiple pregnanc y
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main goal of this validation study is to assess accuracy and reliability of monitoring of the fetal heart rate (FHR) by non-invasive fetal ECG (NI-fECG) using the Atlantis/Parides device. Since conduction of electrical signals may depend on the presence of amniotic fluid, we aim to study both FHR measurements in (part of) the period before membranes have (been) ruptured (in comparison to Doppler ultrasound (DU)), as well as after membranes have (been) ruptured (in comparison to the fetal scalp electrode (FSE, gold standard)). <br><br>
- Secondary Outcome Measures
Name Time Method