This pilot study aims to explore the possible technical and practical problems that may be encountered when intrapartum NI-fECG monitoring is performed (PF2 study). The results of this pilot study will be the basis for a larger validation study…
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is qualitative and descriptive of nature, based on a
collection of practical and/or technical problems within the 50 NI-fECG
monitorings.
Secondary outcome
Secondary study parameters are signal quality and signal loss. The two methods
(FSE and NI-fECG) will be compared regarding signal quality and signal loss
(FSE serves as gold standard). Also, fECG waveform details will be analysed and
relevant information will be correlated to several clinical maternal and fetal
parameters. furthermore, the EHG signals retrieved with the NI-fECG wil be
analysed.
Background summary
Since there is much debate about the poor specificity of the cardiotocogram
(CTG), additional techniques for fetal surveillance 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), 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 both an accurate fetal heart rate (FHR) and information on the
fetal ECG morphology, both in a non-invasive way.
Study objective
This pilot study aims to explore the possible technical and practical problems
that may be encountered when intrapartum NI-fECG monitoring is performed (PF2
study). The results of this pilot study will be the basis for a larger
validation study towards clinical implementation of NI-fECG monitoring (VF2
study).
Study design
This pilot study is designed as 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 De Run 4600
Veldhoven 5504 DB
NL
De Run 4600 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
< 18years 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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57833.015.16 |