Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

Birmingham Women's NHS Foundation Trust

Status: Enrolling

Conditions: Telemonitoring; High Risk; Telemedicine; Cardiotocography; Pregnancy

Treatments: Device: Pregnabit Pro device and PregnaOne platform

Study type: Interventional

Funder types: Other

Identifiers

NCT07124325

27-6-194

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Home antenatal CTG monitoring

Experimental group

Description:

Participants will be asked to use the remote monitoring devices one a week for a 1 hour each time for up to 6 weeks or until delivery. Participants are eligible if they are aged 18 over over, 32+0 gestation onwards, singleton pregnancy, able to speak English and have at least one of 6 high-risk pregnancy conditions.

Treatment:

Device: Pregnabit Pro device and PregnaOne platform