Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06859177

Remote Electrophysiological Cardiotocography (eCTG) Feasibility in Complicated Pregnancies From 32 to 37 Weeks Gestation Using Home@Hospital Monitoring

Led by Maxima Medical Center · Updated on 2025-09-26

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

M

Maxima Medical Center

Lead Sponsor

E

Eindhoven University of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of using remote electrophysiological cardiotocography (eCTG) monitoring for women with complicated pregnancies between 32 and 37 weeks of gestation. This study aims to assess the success rate of self-administered eCTG measurements along with maternal and perinatal outcomes, patient and healthcare professional satisfaction, and antenatal costs. The study is a single-center, interventional cohort trial focused on remote monitoring in a home and hospital setting. Participants will use the Nemo Remoteae device to perform daily self-administered eCTG monitoring for 30 to 90 minutes in a Home@Hospital setting or at least twice weekly at the outpatient clinic. Alongside eCTG monitoring, participants will self-measure their blood pressure, heart rate, and temperature, and enter these data along with symptoms and concerns into a smartphone application. The study period includes monitoring from inclusion until 37 weeks of gestational age or delivery if earlier. During the study, participants will complete questionnaires at three different times to assess their wellbeing and satisfaction with the remote monitoring and overall care. Researchers will track the number of successful eCTG measurements, changes in monitoring methods, maternal and neonatal health outcomes, and healthcare costs. The study includes follow-up for maternal and neonatal conditions up to six weeks post-delivery, ensuring comprehensive observation of safety and effectiveness measures throughout pregnancy and after childbirth.

CONDITIONS

Brief Title

Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Pregnant with a single baby between 32 weeks and 36 weeks plus 6 days gestation
  • Any indication for fetal monitoring at least twice per week, such as pre-eclampsia, fetal growth restriction, or preterm pre-labor rupture of membranes
  • Absence of exclusion criteria more than 24 hours after admission
  • Oral and written informed consent obtained
Not Eligible

You will not qualify if you...

  • Need for intravenous medication
  • Blood pressure over 160/110 mmHg
  • Absent or reversed umbilical artery blood flow
  • Presence of HELLP syndrome
  • Obstetric intervention expected within 48 hours due to conditions like non-reassuring cardiotocography, active vaginal bleeding, signs of placental abruption, meconium-stained amniotic fluid, or chorioamnionitis
  • Clinical diagnosis of sepsis with low blood pressure
  • Insufficient knowledge of Dutch or English
  • Inability to understand instructions for the Nemo Remote device or patient information
  • Fetal or maternal cardiac arrhythmias
  • Skin conditions preventing abdominal patch placement
  • Use of external or implanted electrical stimulators like TENS or pacemakers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - From inclusion up to 37 weeks of gestational age or until delivery if earlier

Participants self-administer remote electrophysiological cardiotocography (eCTG) monitoring daily at home or at least twice weekly at the outpatient clinic between 32 and 37 weeks of pregnancy.

Daily monitoring at home or at least twice weekly visits at outpatient clinic

Follow-up

Duration - Up to 6 weeks after delivery

Participants are monitored for maternal and neonatal outcomes up to 6 weeks post-delivery.

Approximately 1 to 2 visits post-delivery

Trial Site Locations

Total: 1 location

1

Maxima Medical Center

Veldhoven, North Brabant, Netherlands, 5504DB

Actively Recruiting

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Research Team

S

Sofie van Weelden, MSc

J

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

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.

Sofie van Weelden, Loes Monen, M Beatrijs van der Hout-van der Jagt...

https://pubmed.ncbi.nlm.nih.gov/41632811