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Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

RecruitingNAAges 18 Years - anyFemaleBirmingham Women's NHS Foundation Trust
NCT07124325 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women aged ≥18 years * Gestational age 32+0 weeks onwards. * Singleton pregnancy. * Able to speak English * Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 6 index conditions (hypertensive disease in pregnancy, reduced fetal growth (small for gestational age and fetal growth restriction) obstetric cholestasis, PPROM, previous history of stillbirth and recurrent reduced fetal movements ) * Able to give written informed consent. * Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices. Exclusion Criteria: * 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. * History of allergic reaction to skin adhesives and/or latex. * Acute or chronic skin lesions and wounds in areas in contact with the device.
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What it tests

  • Pregnabit Pro device and PregnaOne platform
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Where

1 site
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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