Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMaxima Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
Minimum age of 18 years old
Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days
Singleton pregnancy
Pre-eclampsia (PE)
Disqualifiers
Oral and written informed consent is obtained.
An indication for intravenous medication
Blood pressure >160/110 A millimeter of mercury (mmHg)
Absent-/or reversed flow umbilical artery Doppler
Trial design
Design model
Single group
Treatments tested in this trial
Remote eCTG
DeviceDevice: Remote eCTG monitoring A remote self-administered electrophysiological cardiotocography (eCTG) monitoring (using Nemo Remote®), daily in a Home@Hospital setting, or at least twice weekly at the outpatient clinic, between 32 and 37 weeks of pregnancy.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Remote self-administered eCTG monitoring (using Nemo Remote®)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of successful eCTG measurements on the first day of inclusion.
Count of successful\* self-administered eCTG measurements on the first day of inclusion in a Home@Hospital setting, measured in numbers and percentages of total. 1\. Successful\* eCTG measurement the first day at inclusion or; 2. Successful\* following eCTG measurement that same day, repeated because of (reassuring but) insufficient interpretability. and no switch to conventional CTG based on interpretability was needed. \*Successful eCTG including the following: 1. a minimum of 30 minutes eCTG registration; 2. an overall a maximum of 20% signal loss (minutes, seconds); 3. sufficient interpretability according to HCPs clinical interpretation, if not maximum extended until 90 minutes when reassuring but insufficient.
Time frame
On the first day of inclusionSecondary outcomes
1
Number of eCTG measurements
Count of eCTG measurements, measured in numbers and percentages
Time frame
Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery2
Number of days with eCTG measurements
Count of days with eCTG measurements, measured in numbers and percentages.
Time frame
Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery3
Number of successful eCTG measurements
Count of eCTG measurements assessed successful\* at closure by healthcare professional, Success rate, qualified as yes or no measured in numbers and percentages of total. \*Successful eCTG including the following: 1. a minimum of 30 minutes eCTG registration; 2. an overall a maximum of 20% signal loss (minutes, seconds); 3. sufficient interpretability according to HCPs clinical interpretation, if not maximum extended until 90 minutes when reassuring but insufficient. The amount of signal loss will be calculated based on the CTG. Signal loss is defined as minutes without registration of the fetal heart rate
Time frame
Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery4
Number of repeated eCTG measurements
Count of repeated eCTG measurements the same day because of reassuring but insufficient interpretability, qualified as yes or no, measured in numbers and percentages of total.
Time frame
Inclusion up to 37 weeks of gestational age or (when earlier) up to time of deliveryOther outcomes
1
Number of participants with analgesia for pain reduction: epidural or/and remifentanil
Count of participants with analgesia for pain reduction during delivery, qualified as yes or no, measured in numbers and percentages of total.
Time frame
During delivery2
Number of participants with perineal laceration
Count of participants with perineal laceration (grade 1, 2, 3a, 3b, 3c, 4), qualified as yes or no, measured in numbers and percentage of total.
Time frame
Directly after childbirth3
Number of participants with an episiotomy
Count of participants with an episiotomy, qualified as yes or no, measured in numbers and percentages of total.
Time frame
Directly after childbirth4
Number of mothers with an obstetric haemorrhage
Count of mothers with an obstetric haemorrhage, qualified as yes or no, measured in numbers and percentages of total. Obstetric haemorrhage \> 1000 millilitres within 24 hours after giving birth
Time frame
Childbirth up to 24 hours after childbirthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maxima Medical Center
Lead sponsor
Eindhoven University of Technology
Collaborator
Source ClinicalTrials.gov