Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies (HASTA)

Maxima Medical Center

Status: Enrolling

Conditions: Remote Monitoring; Feasibility; Pregnancy Related

Treatments: Device: Remote eCTG

Study type: Interventional

Funder types: Other

Identifiers

NCT06859177

NL87858.015.24 (Registry Identifier)

PPS23-2-03529539 (Other Grant/Funding Number)

W24.066

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Remote self-administered eCTG monitoring (using Nemo Remote®)

Experimental group

Description:

Subjects will receive remote self-administered eCTG monitoring (using Nemo Remote®), daily in a Home@Hospital setting for 30-90 minutes, or at least twice weekly at the outpatient clinic.

Treatment:

Device: Remote eCTG