Remote home-based eCTG fetal heart monitoring for complicated pregnancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional cohort will enroll pregnant participants (32+0 to 36+6 weeks, singleton) who require frequent fetal monitoring and ask them to self-administer a non-invasive fetal ECG (eCTG) recording daily during admission or at least twice weekly as outpatients. Participants will also measure blood pressure, heart rate and temperature, enter measurements and symptoms into a smartphone app, and complete three questionnaires about wellbeing and satisfaction. The primary outcome is the success rate of self-administered eCTG measurements, while secondary outcomes include maternal and perinatal outcomes, patient and healthcare professional satisfaction, and antenatal cost analysis. Data collection and monitoring will take place at a single site with technical collaboration from Eindhoven University of Technology.

Why it matters

Who can join: the full rules

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).

Where it's running

• Maxima Medical Center
  Veldhoven, North Brabant, Netherlands Recruiting

Study contacts

• Principal investigator: Judith O.E.H. van Laar, MD, PhD — Máxima Medical Center, Technical University of Eindhoven
• Study coordinator: Sofie van Weelden, MSc
• Email: s.vanweelden@mmc.nl
• Phone: +31408888384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.