Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBirmingham Women's NHS Foundation Trust
About this trial
The overall aim of this research proposal is to explore the feasibility and acceptability of home antenatal maternal-fetal monitoring technology within a high-risk pregnancy group. The investigators hypothesise that home monitoring is feasible and acceptable to both pregnant women and HCPs.
50 women from a single site will be recruited to use a home cardiotocography (CTG) device alongside routine antenatal care. Participants will use this device once a week, for an hour at a time, for up to 6 weeks or until delivery. The primary outcome is 20 minutes of continuous monitoring. Additional outcomes assess acceptability, adherence and safety.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged ≥18 years
Gestational age 32+0 weeks onwards.
Singleton pregnancy.
Able to speak English
Disqualifiers
Multiple pregnancy.
Fetal abnormalities or a non-viable fetus.
Body mass index (BMI) ≥35
Women with internal cardiac devices such as pacemaker and implantable cardioverter defibrillator.
Trial design
Design model
Single group
Treatments tested in this trial
Pregnabit Pro device and PregnaOne platform
DeviceRemote CTG device and online dashboard for remote pregnancy care
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Home antenatal CTG monitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring.
Completion of an at least 20 minutes of uninterrupted interpretable fetal heart recording which has computerised capability. This will be defined as a percentage derived from the number of monitoring episodes achieving the primary outcome divided by the total number of monitoring episodes.
Time frame
Through study completion, an average of 9 monthsSecondary outcomes
1
The number of participants completing the full schedule of home maternal-fetal monitoring episodes.
Determined as the median number of monitoring episodes completed.
Time frame
Through study completion, an average of 9 months2
The number of women approached who agreed to participate within the study.
Number participants agreeing out of total women approached
Time frame
Pre-intervention3
What are the emotions of participants using home maternal-fetal monitoring.
Pre-intervention questionnaire using the accredited STAI anxiety questionnaire.
Time frame
Pre-intervention4
What are the emotions of participants using home maternal-fetal monitoring and is there an impact before and after a singular monitoring episode?
Questionnaire using the accredited STAI anxiety questionnaire at several time points whilst using the home monitoring device. Results compared pre and post monitoring episode to determine a if there is a discriminative impact on anxiety scores whilst using the home monitoring device. Results will be displayed graphically and compared using P value.
Time frame
Through study completion, an average of 9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov