A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
Condition: Fetal Distress; Fetal Heart Rate Disorder Nos
MeSH terms: Fetal Distress
Study type: Observational

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.
    

Detailed description: 
      In the United Kingdom (UK) stillbirth is defined as the death of a fetus before birth and
      after 24 weeks gestation. The incidence of stillbirth in the UK was 4.6 per 1000 in 2014. The
      annual rate of reduction was 1.4%, a rate considerably lower than other high income
      countries, such as Poland (4.5%) and Netherlands (6.8%), demonstrating that more can be done
      to reduce stillbirth rates in the UK. Stillbirths are often preceded by a series of adaptive
      changes, including changes in fetal heart rate (FHR) and reduced fetal movement. Fetal
      monitoring serves, in part, to identify these changes so that appropriate intervention can be
      initiated and adverse outcomes prevented. However, currently used forms of fetal monitoring,
      including Doppler ultrasound and cardiotocography, cannot provide an objective, longitudinal
      view of fetal wellbeing and do not significantly reduce stillbirth rates. A continuous fetal
      monitor could identify signs of fetal compromise earlier.

      A recent study found that 45.1% of surveyed clinicians thought that a continuous fetal
      monitor would be beneficial to their practice, although 81.7% also expressed concerns about
      the utility and clinical implementation of such a device. The Monica AN24 monitor is a novel
      continuous fetal monitoring device which records the fetal electrocardiogram (fECG) via
      trans-abdominal electrodes. Monica AN24 has been shown to have good recording quality though
      one study reported an association between recording quality and gestational age. The effect
      of the device on maternal anxiety is not known. All studies assessing acceptability of the
      device to women have focused on the intrapartum period or during induction of labor.
      Consequently, a prospective observational cohort study is needed to assess the acceptability
      of the Monica AN24 device in the context of antenatal care, as is further exploration of
      factors affecting recording quality of the Monica AN24 device.
    

Intervention name(s): MONICA AN24 device
Intervention type(s): Device
Intervention description(s): Application of MONICA AN24 device and recording for the longest period of fetal heart rate recording possible (limited by battery life)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who have an uncomplicated pregnancy attending the Research Clinics at St Mary's
        Hospital, Manchester.
      
Keywords: Fetal monitoring; Acceptability; Fetal Heart Rate