Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies

NCT ID: NCT06859177

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Pregnancy Related; Remote Monitoring; Feasibility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Remote self-administered eCTG monitoring (using Nemo Remote®)

Subjects will receive remote self-administered eCTG monitoring (using Nemo Remote®), daily in a Home@Hospital setting for 30-90 minutes, or at least twice weekly at the outpatient clinic.

Group Type: EXPERIMENTAL

Remote eCTG

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

NI-fECG

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)

Exclusion Criteria

• Oral and written informed consent is obtained.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eindhoven University of Technology

OTHER

Sponsor Role: collaborator

Maxima Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Judith van Laar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith O.E.H. van Laar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Máxima Medical Center, Technical University of Eindhoven

Locations

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sofie van Weelden, MSc

Role: CONTACT

s.vanweelden@mmc.nl

+31408888384

Judith O.E.H. van Laar, MD, PHD

Role: CONTACT

gynaecologie.secr@mmc.nl

+314-8888384

Facility Contacts

dr. Anke M. Nieuwesteeg

Role: primary

anke.nieuwesteeg@mmc.nl

+31-408889528

Related Links

https://www.toetsingonline.nl/to/ccmo_search.nsf/fABRpop?readform&unids=5E9DC57EAB3DCF44C1258BCD0005C711

Central Committee on Human Research

Other Identifiers

PPS23-2-03529539

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL87858.015.24

Identifier Type: REGISTRY

Identifier Source: secondary_id

W24.066

Identifier Type: -

Identifier Source: org_study_id