Actively Recruiting
The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care
Led by Birmingham Women's NHS Foundation Trust · Updated on 2025-08-15
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of home antenatal maternal-fetal monitoring technology in women with high-risk pregnancies. This study aims to determine if remote monitoring using a cardiotocography (CTG) device is feasible and acceptable to both pregnant women and healthcare providers. Participants are women aged 18 and over with singleton pregnancies at 32 weeks gestation or later who have one of six high-risk pregnancy conditions. Participants will use the Pregnabit Pro device and PregnaOne platform, which are remote CTG monitoring tools, once a week for one hour at a time. This will continue for up to six weeks or until delivery. The study involves only this home monitoring alongside routine antenatal care, with no placebo or comparison group. During the study, researchers will collect CTG traces to assess continuous fetal monitoring quality, adherence to the monitoring schedule, and safety outcomes. They will also evaluate participants' feelings and acceptance of the home monitoring, usability of the device, and any unexpected clinical findings that may require hospital assessment. The study will last on average nine months, covering the monitoring period and data analysis.
CONDITIONS
Brief Title
Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 2 years or older
- Pregnancy at 32 weeks gestation or more
- Single baby pregnancy (no twins or more)
- Able to speak English
- Receiving antenatal care for one of six high-risk conditions: hypertensive disease, reduced fetal growth, obstetric cholestasis, preterm premature rupture of membranes, previous stillbirth, or recurrent reduced fetal movements
- Able to give written informed consent
- Willing to attend hospital immediately if an unexpected finding occurs during home monitoring
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Fetal abnormalities or non-viable fetus
- Body mass index (BMI) of 35 or higher
- Presence of internal cardiac devices such as pacemaker or defibrillator
- History of allergic reaction to skin adhesives or latex
- Acute or chronic skin lesions or wounds where the device contacts the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks or until delivery
Participants use a remote cardiotocography device and online platform for home antenatal monitoring.
Weekly use for 1 hour each time
Trial Site Locations
Total: 1 location
1
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom, B152TG
Actively Recruiting
Research Team
J
Jack Hamer, MBChB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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