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

Fetal Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370822
• Other study ID #: 201920
• Status: Completed
• Start date: June 22, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women with singleton pregnancies attending St. Mary's Hospital, Manchester for antenatal care

• No abnormality identified on ultrasound scan of fetal biometry and umbilical and fetal Doppler indices

• Gestational age >24 weeks

• Able to give informed consent

Exclusion Criteria:

• Multiple pregnancies

• Maternal age <18 years

• Individuals who do cannot speak or do not understand fluent English

• Individuals unable to give informed consent

• Women in active labour

Related Conditions & MeSH terms

• Fetal Distress
• Fetal Heart Rate Disorder Nos

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mother's experience of wearing device	Qualitative Interview conducted within 24 hours of wearing the AN24 device	Immediately following the period (usually 12-24 hours) of wearing MONICA AN24 device
Primary	Change in Maternal Anxiety (GAD-2)	Change in maternal anxiety as assessed by Generalised Anxiety Disorder 2 item (GAD-2)	Maternal completion of the GAD-2 questionnaire before wearing the MONICA AN24 device and immediately following the period of wearing the MONICA AN24 device.
Primary	Change in Maternal Anxiety (Pregnancy Specific Anxiety Score)	Change in maternal anxiety as assessed by Pregnancy Specific Anxiety Score	Maternal completion of the Pregnancy Specific Anxiety Score questionnaire before wearing the MONICA AN24 device and immediately following the period of wearing the MONICA AN24 device.
Primary	Maternal Anxiety (STAI)	Change in maternal anxiety as assessed by State Trait Anxiety Index.	Maternal completion of the STAI before wearing the MONICA AN24 device and immediately following the period of wearing the MONICA AN24 device.
Secondary	Recording quality - defined as the percentage of time the device recorded the fetal heart rate	The recording quality of the Monica AN24 device defined as the percentage of time the device recorded the fetal heart rate) with differing levels of maternal activity and differing gestational ages.	During the 12-24 hour recording period