RecruitingNot ApplicableNCT06859177

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

Sponsor

Maxima Medical Center

Enrollment

60 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether remote electronic fetal heart rate monitoring (eCTG) done at home can safely replace some hospital visits for pregnant women who need frequent fetal monitoring due to pregnancy complications, enabling a "hospital at home" approach. **You may be eligible if...** - You are at least 18 years old - You are between 32 and 36 weeks pregnant with a single baby - You require fetal monitoring at least twice per week due to a complication such as preeclampsia, fetal growth restriction, or premature rupture of membranes - You have been stable in hospital for at least 24 hours before enrolling **You may NOT be eligible if...** - You need IV medication - Your blood pressure is very high (above 160/110 mmHg) - Blood flow to your baby through the umbilical cord is absent or reversed - You have HELLP syndrome (a serious pregnancy complication) - Your doctors expect to need to deliver your baby within 48 hours - You have active bleeding, signs of placental abruption, meconium-stained fluid, or infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICERemote 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.