An observational study in Fetal Distress and Fetal Heart Rate Disorder Nos, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University of Manchester · Observational
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.
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.
37 studies on the registry are indexed under Fetal Distress; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 121 across 12 observational studies indexed under Fetal Distress.
Browse Fetal Distress studies →University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women who have an uncomplicated pregnancy attending the Research Clinics at St Mary's Hospital, Manchester.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Qualitative Interview conducted within 24 hours of wearing the AN24 device
Time frame: 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)
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 (Pregnancy Specific Anxiety Score)
Change in maternal anxiety as assessed by 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.
Maternal Anxiety (STAI)
Change in maternal anxiety as assessed by State Trait Anxiety Index.
Time frame: Maternal completion of the STAI before wearing the MONICA AN24 device and immediately following the period of wearing the MONICA AN24 device.
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.
Time frame: During the 12-24 hour recording period
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2016 to primary completion in Jul 2017, 13 months.
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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