Fetal DistressNCT03370822
A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
An observational study of Fetal Distress and Fetal Heart Rate Disorder Nos, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fetal Distress, Fetal Heart Rate Disorder Nos
- What is being tested?
- MONICA AN24 device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who have an uncomplicated pregnancy attending the Research Clinics at St Mary's Hospital, Manchester.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Distress, Fetal Heart Rate Disorder Nos
- Being tested
- MONICA AN24 device
- Keywords
- Fetal monitoring, Acceptability, Fetal Heart Rate
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MONICA AN24 deviceDevice
Application of MONICA AN24 device and recording for the longest period of fetal heart rate recording possible (limited by battery life)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MONICA AN24 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother's experience of wearing device
Qualitative Interview conducted within 24 hours of wearing the AN24 device
Measured: 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)
Measured: 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
Measured: 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.
Measured: Maternal completion of the STAI before wearing the MONICA AN24 device and immediately following the period of wearing the MONICA AN24 device.
Secondary outcomes (1)
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.
Measured: During the 12-24 hour recording period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start22 Jun 2016
- Primary completion31 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370822
- Sponsor's protocol ID
- 201920
- Status last verified
- May 2018
- First submitted
- 24 Nov 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring
- ClinicalTrials.gov ID
- NCT03370822
- Acronym / sponsor ID
- 201920
- Conditions
- Fetal Distress, Fetal Heart Rate Disorder Nos
- Keywords
- Fetal monitoring, Acceptability, Fetal Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Device: MONICA AN24 deviceWomen 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who have an uncomplicated pregnancy attending the Research Clinics at St Mary's Hospital, Manchester.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MONICA AN24 deviceApplication of MONICA AN24 device and recording for the longest period of fetal heart rate recording possible (limited by battery life) | Device | Study Participants |
Primary outcome
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.
1 secondary outcome
Recording quality - defined as the percentage of time the device recorded the fetal heart rate
Time frame: During the 12-24 hour recording period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
Related trials for Fetal Distress
Not yet recruitingObservational study
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Ophthalmic Artery, Labor and Delivery
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Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
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The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Distress and Fetal Heart Rate Disorder Nos, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother's experience of wearing device (time frame: Immediately following the period (usually 12-24 hours) of wearing MONICA AN24 device). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.