Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care
Launched by BIRMINGHAM WOMEN'S NHS FOUNDATION TRUST · Aug 8, 2025
Trial Information
Current as of September 07, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using a home monitoring device to check the baby’s health during high-risk pregnancies is practical and acceptable for both pregnant women and healthcare providers. Specifically, the study involves a device called cardiotocography (CTG), which records the baby’s heartbeat and movements. The goal is to see if women can use this device at home once a week for about an hour, alongside their usual prenatal care, and if this method is safe and easy to follow.
Women who are 18 years or older, pregnant with one baby at 32 weeks or later, and receiving care for certain pregnancy concerns (like high blood pressure, smaller-than-average baby growth, or previous pregnancy complications) may be eligible to join. Participants will be asked to use the home CTG device weekly for up to six weeks or until their baby is born, and they should be ready to visit the hospital quickly if anything unusual is found during monitoring. This study is currently recruiting women who meet these criteria and can speak English. It’s important to note that women with multiple pregnancies, certain medical devices, or skin conditions that could interfere with the device are not eligible.
Gender
FEMALE
Eligibility 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.
About Birmingham Women's Nhs Foundation Trust
Birmingham Women's NHS Foundation Trust is a leading healthcare organization dedicated to providing high-quality women's and neonatal services. Committed to advancing clinical research, the Trust plays a pivotal role in conducting innovative clinical trials that aim to improve health outcomes for women and their families. With a multidisciplinary approach, the Trust collaborates with various stakeholders to ensure rigorous scientific standards and ethical practices are upheld in all research initiatives. Its focus on patient-centered care and commitment to excellence positions Birmingham Women's NHS Foundation Trust as a key contributor to advancements in women's health and medical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, West Midlands, United Kingdom
Patients applied
Trial Officials
Jack Hamer, MBChB
Principal Investigator
Birmingham Women's and Children's NHS Foundation Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported