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

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

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.

Study Overview

• Status: Completed
• Conditions: Fetal Distress; Fetal Heart Rate Disorder Nos
• Intervention / Treatment: Device: MONICA AN24 device

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Central Manchester University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who have an uncomplicated pregnancy attending the Research Clinics at St Mary's Hospital, Manchester.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Participants; Women who have continuous fetal monitoring using the MONICA AN24 device. The MONICA AN24 is a wearable monitor with five adhesive electrodes placed on the mother's abdomen. This records the fetal heart rate, maternal heart rate and uterine contractions.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Manchester

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2016
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Acceptability; Fetal Heart Rate; Fetal monitoring
• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: 201920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No