A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
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|ClinicalTrials.gov Identifier: NCT03370822|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment|
|Fetal Distress Fetal Heart Rate Disorder Nos||Device: MONICA AN24 device|
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|
|Estimated Enrollment :||20 participants|
|Official Title:||A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring|
|Actual Study Start Date :||June 22, 2016|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
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)
- Mother's experience of wearing device [ Time Frame: Immediately following the period (usually 12-24 hours) of wearing MONICA AN24 device ]Qualitative Interview conducted within 24 hours of wearing the AN24 device
- Change in Maternal Anxiety (GAD-2) [ Time Frame: 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 as assessed by Generalised Anxiety Disorder 2 item (GAD-2)
- Change in Maternal Anxiety (Pregnancy Specific Anxiety Score) [ Time Frame: 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. ]Change in maternal anxiety as assessed by Pregnancy Specific Anxiety Score
- Maternal Anxiety (STAI) [ Time Frame: Maternal completion of the STAI before wearing the MONICA AN24 device and immediately following the period of wearing the MONICA AN24 device. ]Change in maternal anxiety as assessed by State Trait Anxiety Index.
- Recording quality - defined as the percentage of time the device recorded the fetal heart rate [ Time Frame: During the 12-24 hour recording period ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370822
|Central Manchester University Hospitals NHS Foundation Trust|
|Manchester, United Kingdom, M13 9WL|