Feasibility of Remote ECTG Monitoring Home@Hospital in Complicated Pregnancies

Launched by MAXIMA MEDICAL CENTER · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to monitor the health of pregnant women who have complicated pregnancies by using a remote device called eCTG. The goal is to see if women can successfully use this device at home or in the hospital to check their baby's heart rate and contractions. The study will also look at how well the mothers and babies are doing, how satisfied the patients and healthcare providers are with this monitoring, and the costs involved in the process.

To be eligible for this trial, participants must be women who are at least 18 years old and are between 32 to 36 weeks pregnant with a single baby. They should have specific health conditions that require regular monitoring, such as high blood pressure or slow fetal growth. During the trial, participants will measure their heart rate, blood pressure, and temperature daily, entering this information into a mobile app. They will also answer questionnaires about their experience and wellbeing throughout the study. It's important to note that this trial is not yet recruiting participants, so it isn't open for enrollment right now.

Gender

FEMALE

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).