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Ambulatory Fetal Heart Rate Monitoring in Small Babies

NCT02627482 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2017-05-01

No results posted yet for this study

Summary

Most babies who measure small during pregnancy are born healthy. However, some are small because they are not growing as expected, usually because the placenta (the baby's 'life support' system) is not working properly. These babies are at greatly increased risk of dying before birth, and need to be delivered before they become poorly.

Scans and electronic heartrate monitoring are currently used to monitor these babies. But they can only be used for short periods and don't always provide enough information to show when to deliver the baby.

A small light monitor has been developed that safely records the baby's heart rate for up to 16hrs by measuring electrical activity through sticky patches on the mum's skin (like a normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the heart rate over a longer time may help with decisions about the timing of the delivery and could prevent stillbirth, the aim of our future study. This will include large numbers of women carrying small babies. Before the investigators can do this the investigators need to know whether:

1. Wearing the monitor for 16hrs is practical and acceptable to pregnant women
2. The monitor can provide useful information on the baby's heart rate at different stages of pregnancy.

Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on two occasions, for 16hrs each time. The women will describe what they think about wearing the monitor by completing questionnaires.

The data from the monitor will be downloaded and compared with the woman's medical notes after the participant has delivered her baby. Results from this study will be publicised and will help with the design of the investigators future study into the usefulness of this monitor.

Conditions

  • High Risk Pregnancy

Interventions

DEVICE

Fetal heart rate monitor (Monica AN24)

The AN24 is a portable, battery powered device, developed in the UK and designed to monitor passively an unborn baby in the antenatal period. The device is CE marked and is attached via a cable assembly which in turn attaches to five standard disposable electrodes placed on the abdomen of a pregnant woman. It is intended for ambulatory use in either the home or hospital environment. The AN24 has had rigorous checks in the UK and has been used in many European countries. No hazards have been identified that could compromise the safety of, or cause harm to the fetus or the mother. The only potential issue identified is a local reaction under the electrodes. Nonetheless, the electrodes used are the standard disposable ECG electrodes, used routinely for adult ECG measurements.

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-11-08
Completion
2016-11-11

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 NCT02627482 on ClinicalTrials.gov