Home fetal heart and contraction monitoring for high-risk pregnancies
The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Birmingham Women's NHS Foundation Trust Government |
| Locations | 1 site (Birmingham) |
| Trial ID | NCT07124325 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.