To determine the workability of the non-invasive abdominal electrode patch for implementation in clinical practice.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes: Percentage of switch to FSE and tocodynamography during labor
and the reason of switch.
Secondary outcome
Secondary outcomes:
Percentage and result of fetal blood sampling (FBS) in the primary and
secondary stage of labor.
Association of EHG pattern and the amount of blood loss within the first one
and a half hour postpartum.
Assocation of EHG pattern within the first one and a half hour postpartum and
medication use and placental expulsion.
Association of EHG pattern and initiation of labor analgesia.
Other outcomes: This sample of patients will be a part of a greater study
population to evaluate the effects of clinical implementation of NI-fECG and
EHG monitoring on neonatal and maternal outcome. Retrospectively we will
correlate fECG waveform details to clinical parameters and outcomes.
Background summary
Cardiotocography is used for continuous fetal monitoring during labor. Fetal
heart rate (FHR) and uterine activity (UA) measured over time generates a
cardiotocogram (CTG). Clinical decisions and interventions, such as an
operative delivery, are based on the interpretation of the CTG. Invasive
measurements generate the most accurate FHR by using fetal scalp electrode
(FSE) and UA by using intra-uterine pressure catheter (IUPC). However, invasive
measurement has several contra-indications, can only be used when membranes
have ruptured and has the risks of complications. An alternative method of FHR
and UA measurement is electrophysiology. Nemo Healthcare® developed a wireless
abdominal electrode patch for measurement of the FHR and UA by using
non-invasive fetal electrocardiography (NI-fECG) and electrohysterography
(EHG). The Nemo® Fetal Monitoring System (NFMS) is validated in the F2 study
(NL63732.015.17) and has been CE-approved in October 2018. However, the
workability of the NFMS during labor needs to be studied.
Study objective
To determine the workability of the non-invasive abdominal electrode patch for
implementation in clinical practice.
Study design
A prospective observational pilot study
Study burden and risks
Participation in this pilot study is expected not to cause any risk for the
women or fetus, because if registration using the abdominal patch is
insufficient, a switch to the conventional CTG (FSE and TOCO) will be made
which is available in each labor ward. From that moment on decisions will be
based on the conventional CTG monitoring system, which is standard care.
The advantage of the NFMS is that it is wireless (allowing women to move during
delivery), non-invasive and has the potential to improve maternal and neonatal
outcomes. Information on EHG pattern (UA) and the amount of blood loss within
the first hour postpartum may be used in the future for management to prevent
postpartum hemorrhage.
There is a very small chance that participating patients experience skin
irritation or minor allergic (local) reaction to the skin electrodes from the
abdominal patch.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Pregnant women with a gestational age between 36 and 42 weeks.
- Admission to the labor ward because of labor and indication for fetal
monitoring during labor.
- Singleton fetus in cephalic presentation.
- Oral and written informed consent is obtained.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Women under the age of 18 years.
- Language barrier (other language than Dutch or English)
- Women with a multiple pregnancy.
- Fetal cardiac arrhythmias (detected and confirmed during pregnancy by
ultrasound).
- Contraindications to abdominal patch placement (dermatologic diseases of the
abdomen precluding preparation of the abdomen with abrasive paper).
- Women in labor taking a bath (because the Bluetooth signal is disturbed and
monitoring is impossible). It is possible to take a shower.
- Women connected to external or implanted electrical stimulators, such as
Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of
disturbance of the electrophysiological signal we want to measure, not because
of danger for mother or child).
- Contraindications for monitoring using a FSE (coagulation disorders and
maternal infections like HIV or hepatitis)
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 | NL68439.015.19 |
| Other | NL8024 |