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

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.

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).