Clinical trial NCT06859177: Feasibility of Remote ECTG Monitoring Home@Hospital in Complicated Pregnancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
First posted: 2025-03-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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 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).

Primary outcomes:
measure: Number of successful eCTG measurements on the first day of inclusion.
timeFrame: On the first day of inclusion
Secondary outcomes:
measure: Number of eCTG measurements
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Number of days with eCTG measurements
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Number of successful eCTG measurements
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Number of repeated eCTG measurements
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Number of switches of monitoring method from eCTG to conventional CTG monitoring, because of insufficient signal quality.
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Switch from eCTG to conventional CTG because of maternal and/or fetal reason
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Success rate of conventional CTG measurement after switch from eCTG
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Number of eCTG measurements prematurely closed
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery
measure: Number of participants with irritation abdominal skin
timeFrame: Inclusion up to 12 hours after removal last abdominal eCTG patch
measure: Number of "unscheduled antenatal visits"
timeFrame: Inclusion up to 37 weeks of gestational age or (when earlier) to time of delivery
measure: Duration of pregnancy at inclusion (days)
timeFrame: At inclusion
measure: Maternal diagnosis at inclusion
timeFrame: At inclusion
measure: Reason(s) for fetal monitoring at inclusion
timeFrame: At inclusion
measure: Number of mothers admitted to the Intensive Care Unit
timeFrame: Inclusion up to 6 weeks post-delivery
measure: Number of maternal mortality
timeFrame: Inclusion up to 6 weeks post-delivery
measure: Number of participants with emergency and or secondary cesarean section
timeFrame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)
measure: Number of participants diagnosed with abruptio placentae
timeFrame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)
measure: Number of participants diagnosed with eclampsia
timeFrame: Inclusion up to 6 weeks post-delivery
measure: Number of participants diagnosed with HELLP syndrome
timeFrame: Inclusion up to 6 weeks post-delivery
measure: Number of participants diagnosed with prolapse of the umbilical cord
timeFrame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)
measure: Composite of maternal morbidity
timeFrame: Start pregnancy up to 6 weeks post-delivery
measure: Number of perinatal mortality
timeFrame: Inclusion up to 7 completed days of life
measure: Number of fetal mortality
timeFrame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)
measure: Number of neonatal mortality
timeFrame: After the seventh day but before the 28th day of life
measure: Duration of pregnancy at childbirth (days)
timeFrame: Start pregnancy up to childbirth (up to maximum 42 weeks of gestation)
measure: Number of neonates with involvement of a pediatrician
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number op neonates with dysmaturity (birthweight <p3, p3-p10, <p10)
timeFrame: At childbirth (maximum 42 weeks of gestation)
measure: Number of neonates with a congenital anomality
timeFrame: At childbirth
measure: Number of neonates with hypoxic ischemic encephalopathy (HIE)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with Neonatal Respiratory Distress Syndrome (RDS)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with Meconium Aspiration Syndrome (MAS)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with convulsions
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with a Clinical Early Onset Sepsis (EOS)
timeFrame: Childbirth up to the first 72 hours, or up to 7 days after childbirth
measure: Number of neonates with confirmed early onset sepsis (EOS)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with an Apgar score at 5 minutes below 7
timeFrame: 5 minutes after childbirth
measure: Number of neonates with an umbilical cord blood pH <7.05
timeFrame: Directly after childbirth
measure: Number of neonates with neonatal asphyxia
timeFrame: Directly after childbirth up to 5 minutes after childbirth
measure: Number of neonates admitted to the Neonatal Medium Care Unit (NMCU)
timeFrame: Childbirth up to 6 weeks after delivery
measure: Number of neonatal morbidities (composite)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with at least one neonatal diagnosis (composite)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of neonates with the need for intubation and/or mechanical ventilation
timeFrame: Childbirth up to 72 hours after childbirth
measure: Duration admission to the Neonatal Medium Care Unit (days)
timeFrame: Childbirth up to 6 weeks after delivery
measure: Number of neonates with an admission to the Neonatal Intensive Care Unit (NICU)
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Duration of admission to the NICU (neonatal intensive care unit) in days.
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Assessment (twice) using a survey EuroQol including 5 dimensions and 5 levels (EQ5D-5L) to measure patient wellbeing, including visual analog pain scale (VAS)
timeFrame: At inclusion and at 4 weeks post-delivery
measure: Assessment (once) using a surveys (D-QUEST) to measure patient satisfaction of the received monitoring method (device)
timeFrame: At discharge from the hospital, at 37 weeks of gestational age or (when earlier) post-delivery
measure: Assessment (once) using a survey (CSQ-8) to measure patient satisfaction of the overall received care
timeFrame: At 4 weeks post-delivery
measure: Assessment (once) using a survey (D-Quest) to measure Healthcare professional (HCP) satisfaction of the given monitoring method.
timeFrame: At the moment when the last participant has delivered or has reached the gestational age of 37 weeks, assessed up to 1 month.d
measure: Antenatal costs as a business case model
timeFrame: Inclusion up to moment of start delivery (antenatal period), assessed up to maximum 42 weeks of gestation.
Other outcomes:
measure: Number of participants with analgesia for pain reduction: epidural or/and remifentanil
timeFrame: During delivery
measure: Number of participants with perineal laceration
timeFrame: Directly after childbirth
measure: Number of participants with an episiotomy
timeFrame: Directly after childbirth
measure: Number of mothers with an obstetric haemorrhage
timeFrame: Childbirth up to 24 hours after childbirth
measure: Number of mothers with a thromboembolic event
timeFrame: Inclusion up to 6 weeks post-delivery
measure: Number of mothers with an uterine rupture
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of mothers with a suspected or confirmed postpartum infection requiring antibiotics
timeFrame: Childbirth up to 6 weeks post-delivery
measure: Number of mothers with a postpartum anemia due to postpartum haemorrhage with requires red cell transfusion
timeFrame: Childbirth up to 6 weeks post-delivery
Locations:
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
state: Noord-Brabant
Study officials:
affiliation: Máxima Medical Center, Technical University of Eindhoven
name: Judith O.E.H. van Laar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: