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
Qualifiers
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
Treatments tested in this trial
- Pregnabit Pro device and PregnaOne platform
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
1Birmingham Women's and Children's NHS Foundation TrustB152TG, Birmingham United Kingdom
Sponsors and collaborators
Birmingham Women's NHS Foundation Trust
Lead sponsor
Source ClinicalTrials.gov