MedTrace Logo

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

NCT07124325 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • High Risk
  • Telemonitoring
  • Telemedicine
  • Cardiotocography

Interventions

DEVICE

Pregnabit Pro device and PregnaOne platform

Remote CTG device and online dashboard for remote pregnancy care

Sponsors & Collaborators

  • Birmingham Women's NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Jack Hamer, MBChB · Birmingham Women's and Children's NHS Foundation Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2026-02-01
Completion
2026-04-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124325 on ClinicalTrials.gov