This study aims to validate NI-fECG monitoring as an accurate and reliable monitoring technique for FHR, MHR and UA surveillance during labour. The aim of this validation is to work towards clinical implementation of NI-fECG monitoring.
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is to assess the accuracy of the NI-fECG
monitorings. This will be compared to the accuracy of the gold standard FSE
monitoring.
Secondary outcome
To validate the monitoring of maternal heart rate measured by the
Atlantis/Parides system as compared to standard methods of monitoring maternal
heart rate during labour (for instance pulse oximetry or the pulse Doppler
signal provided by the TOCO button).
To compare the EHG (electrohysterogram) signals retrieved by the Parides patch
with the tocodynamometer (TOCO) or intra-uterine pressure catheter (IUPC).
Background summary
Since there is much debate about the poor specificity of the cardiotocogram
(CTG), additional techniques for fetal surveillance and contrationmonitoring
during labour have been developed. The disadvantage of these techniques, such
as fetal blood sampling (FBS) and ST-analysis of the fetal electrocardiogram
(ECG; STAN) and the intra-uterine pressure catheter, is that they are invasive
and can only be performed when membranes have ruptured. Non-invasive fetal ECG
(NI-fECG) monitoring can overcome these disadvantages, by providing an accurate
fetal heart rate (FHR), maternal heart rate (MHR), uterine activity (UA) and
information on the fetal ECG morphology, all in a non-invasive way.
Study objective
This study aims to validate NI-fECG monitoring as an accurate and reliable
monitoring technique for FHR, MHR and UA surveillance during labour. The aim of
this validation is to work towards clinical implementation of NI-fECG
monitoring.
Study design
a cross-sectional observational study, with a prospective nature, that will
take place in the MMC Veldhoven.
Study burden and risks
Participation in this pilot study will cause no risk for the patient. There is
a very small chance that participating patients experience skin irritation or a
minor allergic (local) reaction to the skin electrodes from the NI-fECG patch.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
Pregnant women who are in labour, carrying a healthy, singleton fetus in cephalic presentation, with a gestational age between 36 and 42 weeks
Exclusion criteria
- < 18 years of age
- Multiple pregnancy
- Fetus in breech position
- Women with signs of fetal distress (abnormal CTG requiring immediate intervention)
- Women with a positive hepatitis B/C or HIV serology
- Women with idiopathic thrombocytopenia or other inheritable hematologic diseases
- Dermatologic disease of the abdomen precluding preparation of the abdomen with abrasive paper - Women in labour taking a shower or bath and women connected to external or implanted electrical stimulators
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63732.015.17 |
| OMON | NL-OMON24697 |