Remote eCTG: Device: Remote eCTG monitoring
A remote self-administered electrophysiological cardiotocography (eCTG) monitoring (using Nemo Remote®), daily in a Home@Hospital setting, or at least twice weekly at the outpatient clinic, between 32 and 37 weeks of pregnancy.
Study summary
The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting.
The primary objective is to assess:
• The success rate of the self-administered eCTG measurement
The secondary objective is to asses:
* Maternal and perinatal outcomes
* Patients wellbeing and satisfaction.
* Healthcare professionals' (HCPs') satisfaction
* Analysis of antenatal costs
Participants will:
* Self-administer remote eCTG monitoring once daily during admission (or at least twice weekly at the outpatient clinic)
* Self-measure their blood pressure, heartrate and temperature
* Enter the measurements, symptoms and worries into an application on their telephone.
* Answer questionnaires at 3 moments during the study, assessing their wellbeing and satisfaction of the received care and self-administered remote monitoring device.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following 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.):
* Pre-eclampsia (PE)
* Fetal growth restriction (FGR)
* Preterm pre-labor rupture of membranes (PPROM)
* Absence of exclusion criteria \> 24 hours after admission.
* 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:
* An indication for intravenous medication
* Blood pressure \>160/110 A millimeter of mercury (mmHg)
* Absent-/or reversed flow umbilical artery Doppler
* Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)
* Obstetric intervention expected \<48 hours, e.g. due to:
* Non reassuring cardiotocography (CTG)
* Active vaginal blood loss
* Signs of abruption placentae
* Meconium stained amniotic fluid
* Signs of chorioamnionitis
* Patients admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).
* 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).
Primary outcome measure(s)
Number of successful eCTG measurements on the first day of inclusion. — On the first day of inclusion Count of successful\* self-administered eCTG measurements on the first day of inclusion in a Home@Hospital setting, measured in numbers and percentages of total.
1\. Successful\* eCTG measurement the first day at inclusion or; 2. Successful\* following eCTG measurement that same day, repeated because of (reassuring but) insufficient interpretability. and no switch to conventional CTG based on interpretability was needed.
\*Successful eCTG including the following: 1. a minimum of 30 minutes eCTG registration; 2. an overall a maximum of 20% signal loss (minutes, seconds); 3. sufficient interpretability according to HCPs clinical interpretation, if not maximum extended until 90 minutes when reassuring but insufficient.
Trial sites (1)
Facility
City
Region
Status
Maxima Medical Center
Veldhoven
North Brabant
Recruiting
More Maxima Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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