NCT06859177Recruiting
Feasibility of Remote eCTG Monitoring Home@Hospital in 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
Source: ClinicalTrials.gov · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Nov 2024
- Start date
- 25 Mar 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Maxima Medical Center
- NCT number
- NCT06859177
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 25 Mar 2025 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- An indication for intravenous medication
Other illness
- Fetal and/or maternal cardiac arrhythmias
- Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
Lab values
- Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)
Other
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Blood pressure \>160/110 A millimeter of mercury (mmHg)
- Absent-/or reversed flow umbilical artery Doppler
- 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
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maxima Medical Center Coordinator of this site? Confirm its status | Veldhoven | Netherlands | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.