Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies

Recruiting now · Not applicable

Conditions studied: Pregnancy Related, Remote Monitoring, Feasibility

In brief

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.

Key facts

Study ID

NCT06859177

Run by

Maxima Medical Center

People needed

60

Starts

2025-03-25

Expected to finish

2026-12-01

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Maxima Medical Center — Veldhoven, North Brabant, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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