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A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device

NCT03370822 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2018-05-02

No results posted yet for this study

Summary

A stillbirth describes when a baby dies after 24 weeks of pregnancy and before being born. In the UK there are roughly 9 stillbirths every day. Normally, before a stillbirth occurs changes such as a slower heart rate and reduced movement take place. Fetal monitoring attempts to detect these changes so that babies can be delivered before they become severely ill. If a baby could be monitored continuously then these changes could be detected earlier. However, current forms of fetal monitoring, such as ultrasound, cannot be used for long periods of time and do not significantly reduce stillbirth rates. The Monica AN24 device is a continuous monitor which records the baby's heart rhythm using sensors placed on the mother's abdomen. As this is a new device there is little evidence about how well it works. In this project women will be asked how they feel about the device after wearing it. Doctors and midwives will also be asked about their views of the device. The effect of the mother's movement and the age of the baby on how well the Monica AN24 can record the baby's heart rhythm will also be assessed.

Conditions

  • Fetal Distress
  • Fetal Heart Rate Disorder Nos

Interventions

DEVICE

MONICA AN24 device

Application of MONICA AN24 device and recording for the longest period of fetal heart rate recording possible (limited by battery life)

Sponsors & Collaborators

  • University of Manchester

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-22
Primary Completion
2017-07-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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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 NCT03370822 on ClinicalTrials.gov