Remote home-based eCTG fetal heart monitoring for complicated pregnancies

Remote Electrophysiological Cardiotocography (eCTG), Evaluation of Feasibility in (a Selected Group of) Complicated Pregnancies From 32 Until 37 Weeks Gestational Age in a Home@Hospital Setting: a Prospective Cohort Study

This project tests whether people with complicated pregnancies can self-use a non-invasive fetal ECG (eCTG) device at home or in-hospital to monitor their baby's heart and their own vitals.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Maxima Medical Center (other)
• Locations: 1 site (Veldhoven, North Brabant)
• Trial ID: NCT06859177 on ClinicalTrials.gov

What this trial studies

This single-center interventional cohort will enroll pregnant participants (32+0 to 36+6 weeks, singleton) who require frequent fetal monitoring and ask them to self-administer a non-invasive fetal ECG (eCTG) recording daily during admission or at least twice weekly as outpatients. Participants will also measure blood pressure, heart rate and temperature, enter measurements and symptoms into a smartphone app, and complete three questionnaires about wellbeing and satisfaction. The primary outcome is the success rate of self-administered eCTG measurements, while secondary outcomes include maternal and perinatal outcomes, patient and healthcare professional satisfaction, and antenatal cost analysis. Data collection and monitoring will take place at a single site with technical collaboration from Eindhoven University of Technology.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with a singleton pregnancy at 32+0–36+6 weeks who require fetal monitoring at least twice weekly for conditions like pre-eclampsia, fetal growth restriction, or PPROM and who can provide informed consent and use a smartphone.

Not a fit: Patients needing intravenous medication, with very high blood pressure (>160/110 mmHg), absent or reversed umbilical artery flow, HELLP syndrome, or those expected to need obstetric intervention within 48 hours are unlikely to benefit and should remain in-hospital.

Why it matters

Potential benefit: If successful, this approach could enable safe remote monitoring that reduces in-person visits and gives patients more control while maintaining fetal surveillance.

How similar studies have performed: Small feasibility and pilot programs of home CTG and other non-invasive fetal monitoring technologies have shown promise, but home eCTG monitoring remains relatively novel and not yet widely validated.

Eligibility criteria

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).

Where this trial is running

Veldhoven, North Brabant

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

Study contacts

• Principal investigator: Judith O.E.H. van Laar, MD, PhD — Máxima Medical Center, Technical University of Eindhoven
• Study coordinator: Sofie van Weelden, MSc

Conditions: Pregnancy Related, Remote Monitoring, Feasibility, feasibility, remote, complicated pregnancies, antenatal, Non invasive fetal electrocardiography