Actively Recruiting
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
Led by Maxima Medical Center · Updated on 2025-09-26
60
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
Sponsors
M
Maxima Medical Center
Lead Sponsor
E
Eindhoven University of Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Pregnant with a gestational age between 32+0 and 36+6 weeks
- Singleton pregnancy
- Indication for fetal monitoring at least twice weekly, such as pre-eclampsia, fetal growth restriction, or preterm pre-labor rupture of membranes
- Absence of exclusion criteria more than 24 hours after admission
- Oral and written informed consent obtained
You will not qualify if you...
- Need for intravenous medication
- Blood pressure higher than 160/110 mmHg
- Absent or reversed umbilical artery blood flow detected by Doppler
- Diagnosed with HELLP syndrome
- Obstetric intervention expected within 48 hours due to non-reassuring cardiotocography, active vaginal bleeding, placental abruption, meconium-stained amniotic fluid, or signs of chorioamnionitis
- Clinical diagnosis of sepsis with low blood pressure (septic shock)
- Insufficient knowledge of Dutch or English
- Inability to understand instructions for Nemo Remote® or patient information
- Presence of fetal or maternal cardiac arrhythmias
- Skin conditions preventing abdominal patch placement
- Connected to external or implanted electrical stimulators such as TENS or pacemaker
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maxima Medical Center
Veldhoven, North Brabant, Netherlands, 5504DB
Actively Recruiting
Research Team
S
Sofie van Weelden, MSc
CONTACT
J
Judith O.E.H. van Laar, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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