Home fetal heart and contraction monitoring for high-risk pregnancies
Official title: The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.
Run by Birmingham Women's NHS Foundation Trust · NCT07124325 · Data updated 2026-11-12
This will test whether using a home fetal heart and contraction monitor once a week is practical and acceptable for women with certain high-risk singleton pregnancies from 32 weeks onward.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Birmingham Women's NHS Foundation Trust Government |
| Locations | 1 site (Birmingham) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | February 1, 2026 |
| Study ends | April 1, 2026 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT07124325 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English‑speaking women aged 18 or older with a singleton pregnancy at ≥32+0 weeks receiving antenatal care for specified high‑risk conditions such as hypertensive disorders, fetal growth restriction, obstetric cholestasis, PPROM, prior stillbirth, or recurrent reduced fetal movements.
✕Probably not a fit
Women with multiple pregnancies, known fetal abnormalities or non‑viable fetuses, BMI ≥35, implanted cardiac devices, significant adhesive allergies, or skin lesions in contact areas are excluded and unlikely to benefit from this device-based home monitoring approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Fifty women at a single UK centre will use a Pregnabit Pro cardiotocography device at home once weekly for up to six weeks or until delivery alongside routine antenatal care. Each session aims to record at least 20 minutes of continuous fetal heart and contraction monitoring, which is the primary feasibility outcome. The study will also collect data on adherence, user acceptability for both patients and healthcare professionals, and safety events. Findings will inform whether larger trials or wider implementation of home antenatal monitoring are warranted.
Why it matters
Potential benefit: If successful, home monitoring could enable earlier detection of fetal concerns and reduce some hospital visits by allowing selected high‑risk pregnancies to be monitored safely at home.
How similar studies have gone: Previous pilot projects and small programs have suggested remote fetal heart monitoring can be feasible and acceptable in selected groups, but large randomized trials demonstrating clinical benefit remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom Recruiting
Study contacts
- Principal investigator: Jack Hamer, MBChB — Birmingham Women's and Children's NHS Foundation Trust
- Study coordinator: Jack Hamer, MBChB
- Email: jack.hamer1@nhs.net
- Phone: 0121 472 1377
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.