Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies (NCT06859177) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
Netherlands60 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Absence of exclusion criteria \> 24 hours after admission.
* Oral and written informed consent is obtained.
Exclusion Criteria:
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 pre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of successful eCTG measurements on the first day of inclusion.