RecruitingNot ApplicableNCT07124325

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.

Sponsor

Birmingham Women's NHS Foundation Trust

Enrollment

50 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy Telemedicine High-Risk Telemonitoring Cardiotocography

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria6

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.