Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Number of successful eCTG measurements on the first day of inclusion. [Срок оценки: On the first day of inclusion]

Вторичные конечные точки (12)

• Number of eCTG measurements [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Number of days with eCTG measurements [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Number of successful eCTG measurements [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Number of repeated eCTG measurements [Срок оценки: 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. [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Switch from eCTG to conventional CTG because of maternal and/or fetal reason [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Success rate of conventional CTG measurement after switch from eCTG [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Number of eCTG measurements prematurely closed [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery]
• Number of participants with irritation abdominal skin [Срок оценки: Inclusion up to 12 hours after removal last abdominal eCTG patch]
• Number of "unscheduled antenatal visits" [Срок оценки: Inclusion up to 37 weeks of gestational age or (when earlier) to time of delivery]
• Duration of pregnancy at inclusion (days) [Срок оценки: At inclusion]
• Maternal diagnosis at inclusion [Срок оценки: At inclusion]

Критерии участия

Критерии включения

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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 1 центр

• Maxima Medical Center — Veldhoven

Публикации

• 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

Идентификаторы

NCT: NCT06859177 · W24.066 · PPS23-2-03529539 · NL87858.015.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗