Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies

NCT06859177 | Recruiting DMC

• 3 other identifiers: W24.066PPS23-2-03529539NL87858.015.24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

feasibility; remote; complicated pregnancies; antenatal; Non invasive fetal electrocardiography (NI-fECG); electrophysiological cardiotocography (eCTG); high-risk pregnancies; pregnancy; maternal and fetal monitoring; monitoring; electrophysiological; non invasive; preterm pre-labor rupture of membranes (PPROM); pre-eclampsia (PE); fetal growth restriction (FGR); home monitoring; remote monitoring; second trimester; self-administered; satisfaction

Outcome Measures

Primary Outcomes (1)

• Number of successful eCTG measurements on the first day of inclusion.

  Count of successful\* self-administered eCTG measurements on the first day of inclusion in a Home@Hospital setting, measured in numbers and percentages of total. 1\. Successful\* eCTG measurement the first day at inclusion or; 2. Successful\* following eCTG measurement that same day, repeated because of (reassuring but) insufficient interpretability. and no switch to conventional CTG based on interpretability was needed. \*Successful eCTG including the following: 1. a minimum of 30 minutes eCTG registration; 2. an overall a maximum of 20% signal loss (minutes, seconds); 3. sufficient interpretability according to HCPs clinical interpretation, if not maximum extended until 90 minutes when reassuring but insufficient.

  On the first day of inclusion

Secondary Outcomes (49)

• Number of eCTG measurements

  Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

• Number of days with eCTG measurements

  Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

• Number of successful eCTG measurements

  Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

• Number of repeated eCTG measurements

  Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

• Number of switches of monitoring method from eCTG to conventional CTG monitoring, because of insufficient signal quality.

  Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Other Outcomes (8)

• Number of participants with analgesia for pain reduction: epidural or/and remifentanil

  During delivery

• Number of participants with perineal laceration

  Directly after childbirth

• Number of participants with an episiotomy

  Directly after childbirth

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Remote eCTG

Interventions

Remote eCTG 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.

Also known as: NI-fECG

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxima Medical Center: lead
• Eindhoven University of Technology: collaborator

Study Sites (1)

Maxima Medical Center

Veldhoven, North Brabant, 5504DB, Netherlands

RECRUITING

Related Publications (1)

• van Weelden S, Monen L, van der Hout-van der Jagt MB, van Laar JOEH. Remote electrophysiological cardiotocography (eCTG), evaluation of feasibility in complicated pregnancies from 32 until 37 weeks gestational age in a home@hospital setting (HASTA): A prospective cohort study protocol. PLoS One. 2026 Feb 3;21(2):e0341554. doi: 10.1371/journal.pone.0341554. eCollection 2026.

  PMID: 41632811 DERIVED

Related Links

• Central Committee on Human Research

MeSH Terms

Conditions

Pregnancy Complications; Pre-Eclampsia; Fetal Growth Retardation; Personal Satisfaction

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Judith O.E.H. van Laar, MD, PhD

  Máxima Medical Center, Technical University of Eindhoven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie van Weelden, MSc

CONTACT

+31408888384; s.vanweelden@mmc.nl

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

CONTACT

+314-8888384; gynaecologie.secr@mmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective single center interventional cohort study, self-administered remote electrophysiological cardiotocography (eCTG) in a home@hospital setting between 32 and 37 weeks of pregnancy, patients will complete 3 questionnaires until 4 weeks after delivery, data will be collected until 6 weeks after delivery.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: March 5, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: When requested and after assessment, the anonymous data - presented in this study - will be shared with researchers conducting pregnancy related studies after publication of the study results in a medical journal . Study protocol will be submitted for publication and will be available once published. All data will be stored at Maxima Medical Center (MMC) in Veldhoven, in The Netherlands, for at least 15 years after completion of the study, this is a legal obligation.
• Access Criteria: Anonymous data: researchers conducting pregnancy related studies. Informed Consent Form: researchers conducting pregnancy related studies. Protocol: when admitted for publication, open access.

Locations

NL (1)