To evaluate the feasibility of remote eCTG monitoring in complicated pregnancies between 32-37 weeks in a Home@Hospital setting. Secondary objectives are to evaluate automated interpretation of remote eCTG monitoring and to assess perinatal and…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of successful eCTG measurements in a Home@Hospital setting. This
will be defined as the necessity to switch to conventional CTG based on the
amount of signal loss.
Secondary outcome
Automated interpretation of eCTG monitoring, maternal and perinatal outcomes,
patients- and healtcare givers satisfaction and costs.
Additional outcome: Feasibility of synchronized multimodal acquisitions of
maternal and fetal measurements.
Background summary
Patients with obstetric complications like pre-eclampsia (PE), fetal growth
restriction (FGR) or preterm pre-labour rupture of membranes (PPROM) often need
hospitalisation for fetal and maternal monitoring. Remote home monitoring has
the potential to decrease the psychological and family burden of a hospital
admission and to increase patient satisfaction while reducing health care costs
due to a reduction in antenatal admissions. Previous research shows no
indications that fetal home monitoring of selected complicated pregnancies
imposes additional risks compared to in-hospital monitoring. Due to the
limitations of conventional remote CTG monitoring like signal loss,
electrophysiological cardiotocography (eCTG) has been developed and it is
certified from 21 weeks of pregnancy onward. Since signal quality of eCTG in
the preterm period - due to signal loss - is still unclear, the feasibility
needs to be assessed first. The HASTA study will evaluate the feasibility of
remote eCTG monitoring using non-invasive fetal electrocardiography (NI-fECG),
Nemo Remote® Monitoring (NRM) in a hospital setting, as if the patient is at
home (i.e., Home@Hospital setting). Automated interpretation will also be
evaluated to support the healthcare giver in the future.
Additionally, this study will evaluate the feasibility of synchronized
multimodal acquisitions of maternal and fetal measurements in a small
population, aiming to understand the (patho)physiological mechanisms underlying
cardiovascular function in pregnancy in the future.
Study objective
To evaluate the feasibility of remote eCTG monitoring in complicated
pregnancies between 32-37 weeks in a Home@Hospital setting. Secondary
objectives are to evaluate automated interpretation of remote eCTG monitoring
and to assess perinatal and maternal outcomes, patient- and healtcare
professionals satisfaction and costs. Additional objective is to evaluate the
feasibility of synchronized multimodal acquisitions of maternal and fetal
measurements.
Study design
A single center interventional prospective cohort study.
Intervention
Remote eCTG monitoring (using Nemo Remote®), daily in a Home@Hospital setting
for 30-90 minutes, or at least twice weekly at the out-patient clinic.
Monitoring duration depends on signal quality and interpretability of the eCTG
tracing, and lasts at least 30 minutes, and will be ceased after 90 minutes if
the eCTG signal quality and/or interpretability is then still insufficient.
In 24 patients ultrasound clips of 2 x 5 minutes of the uterine and umbilical
artery Doppler will be collected simultaneously to the eCTG measurement.
Study burden and risks
Participation in this study is expected not to cause any risk for the patient
or fetus. In case eCTG registration is insufficient, a switch to the
conventional CTG can be made. The benefits of eCTG monitoring with Nemo Remote®
include the fact that it is wireless, non-invasive and well positionable
without the help of elastic belts. As a result, repetitive repositioning to
reduce signal loss - as required when using conventional CTG frequently
performed with the support of healthcare professionals (HCPs) - is not needed.
This is beneficial for future implementation of home monitoring throughout
pregnancy, thereby increasing the patient's autonomy. Conducting
self-administered remote eCTG home monitoring in a hospital setting, enables
the evaluation of the feasibility at home - most likely - without any risk to
patient or fetus. Patients using Nemo Remote® have a very small - known and
unrelated to remote monitoring - probability of developing skin irritation or a
minor (local) allergic reaction to the skin electrodes from the abdominal
patch. There is no need for treatment if skin irritation happens, as this will
naturally resolve over the course of days once the patch is removed.
Measurements of the umbilical- and uterine artery are widely applied in routine
obstetric care and are known not to cause any harm to patient and/or fetus (2).
At three moments participants will be asked to fill in digital questionnaires.
All other interventions are standard care. No additional - study-related -
hospital visits or fetal registrations are needed.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
• Minimum age of 18 years old
• Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days
• Singleton pregnancy
• Any indication for fetal monitoring at least twice per week (e.g.): PE, FGR,
PPROM
• Absence of exclusion criteria > 24 hours after admission.
• Oral and written informed consent
Exclusion criteria
• An indication for intravenous medication
• Blood pressure >160/110mmHg
• Absent-/or reversed flow umbilical artery Doppler
• HELLP
• Obstetric intervention expected <48 hours
• Clinical diagnosis of sepsis with hypotension
• Insufficient knowledge of Dutch or English language
• Insufficient comprehension of instruction Nemo Remote® or patient information
• Fetal and/or maternal cardiac arrhythmias
• Contraindications to abdominal patch placement (dermatologic diseases of the
abdomen precluding preparation of the abdomen with abrasive paper)
• Patients connected to an external or implanted electrical stimulator, such as
Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of
disturbance of the electrophysiological signal).
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 | NL87858.015.24 |