High Risk PregnancyNCT02627482
Ambulatory Fetal Heart Rate Monitoring in Small Babies
An observational study of High Risk Pregnancy, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Most babies who measure small during pregnancy are born healthy. However, some are small because they are not growing as expected, usually because the placenta (the baby's 'life support' system) is not working properly. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- Fetal heart rate monitor (Monica AN24)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 11 Nov 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The Investigators will recruit 30 women with a singleton pregnancy (no congenital abnormality) and a customised birth weight ratio of less than 10th centile on ultrasound from the small baby clinic, which is provided at the Fetomaternal Unit (FMU) at the Jessop Wing (JW) Hospital, Sheffield. Each participant will be studied on 2 occasions, 2 to 4weeks apart at their routine hospital visit for serial ultrasound scans.
Who may be able to join
- All women with singleton pregnancy from 28 completed weeks of gestation, suspected to carry small for gestational age (SGA) fetus on ultrasound scan but with no known congenital abnormality will be eligible for inclusion in the study if they agree.
Who cannot join
- Evidence of a major fetal malformation on ultrasound scan
- Clinical suspicion of labour
- Multiple pregnancy
- Involved in another study using a device or medicinal product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Employing Ambulatory Fetal Heart Rate Monitoring in Small for Gestational Age Fetuses at Risk of Stillbirth.
Most babies who measure small during pregnancy are born healthy. However, some are small because they are not growing as expected, usually because the placenta (the baby's 'life support' system) is not working properly. These babies are at greatly increased risk of dying before birth, and need to be delivered before they become poorly.
Scans and electronic heartrate monitoring are currently used to monitor these babies. But they can only be used for short periods and don't always provide enough information to show when to deliver the baby.
Read more
A small light monitor has been developed that safely records the baby's heart rate for up to 16hrs by measuring electrical activity through sticky patches on the mum's skin (like a normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the heart rate over a longer time may help with decisions about the timing of the delivery and could prevent stillbirth, the aim of our future study. This will include large numbers of women carrying small babies. Before the investigators can do this the investigators need to know whether:
- Wearing the monitor for 16hrs is practical and acceptable to pregnant women
- The monitor can provide useful information on the baby's heart rate at different stages of pregnancy.
Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on two occasions, for 16hrs each time. The women will describe what they think about wearing the monitor by completing questionnaires.
The data from the monitor will be downloaded and compared with the woman's medical notes after the participant has delivered her baby. Results from this study will be publicised and will help with the design of the investigators future study into the usefulness of this monitor.
Read the detailed description
Study design:
The study has been designed as a prospective, non randomised, single centre feasibility study to determine the acceptability and reliability of the Monica AN24 device, as a method of long-term fetal heart rate (FHR) monitoring on more than one occasion in the antenatal period.
Objectives of the study:
The proposed feasibility study aims to:
- Assess the recruitment rates and practicality of the study design and protocol.
- Evaluate the acceptability to participants of wearing the device for overnight FHR monitoring on two occasions in pregnancy.
- Measure the success rate of generating good quality overnight FHR data and identify any limitations of the technique.
- Determine response rates to questionnaires
Recruitment The investigators will recruit women from 28 completed weeks of gestation. The investigators will study each participant on two occasions (2-4 weeks apart). Being a feasibility study FHR data obtained during these experiments will not be employed in the routine clinical care of study participants whose care will follow standard patterns of surveillance employed at the Jessop Wing Hospital (JW), Sheffield.
Statistical analysis:
As this is a feasibility study the investigators will employ mainly descriptive analysis. The investigators will report rates of consent, recruitment and acceptability of wearing the AN24 device on two occasions. The investigators shall also report the rates and duration of obtaining valid FHR data when the device is worn. The feasibility and FHR outcome measures will be summarised and will inform design for future definitive studies.
Future work and clinical impact of this research:
The investigators believe that incorporating ambulatory FHR monitoring to the current methods employed to monitor SGA could predict and prevent stillbirth. This is the overarching aim of our future definitive multicentre study which will require collection of longterm FHR data at different stages of pregnancy from at least 500 women carrying small babies. Data captured from our feasibility study will inform the design of our main study and ensure that our design is robust and that all the potential issues identified in the feasibility study have been addressed.
- Conditions
- High Risk Pregnancy
- Being tested
- Fetal heart rate monitor (Monica AN24)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal heart rate monitor (Monica AN24)Device
The AN24 is a portable, battery powered device, developed in the UK and designed to monitor passively an unborn baby in the antenatal period. The device is CE marked and is attached via a cable assembly which in turn attaches to five standard disposable electrodes placed on the abdomen of a pregnant woman. It is intended for ambulatory use in either the home or hospital environment.
The AN24 has had rigorous checks in the UK and has been used in many European countries. No hazards have been identified that could compromise the safety of, or cause harm to the fetus or the mother. The only potential issue identified is a local reaction under the electrodes. Nonetheless, the electrodes used are the standard disposable ECG electrodes, used routinely for adult ECG measurements.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess recruitment rate to the study on first invitation
Measured: one year
To estimate proportion of recruited women who demonstrate willingness to wear the monitor two times
In light of investigator's previous work, no problems are anticipated in achieving 30 recruits in a year. However, study would be deemed successful if at least 80% of participants wear the monitor on second occasion and complete the study
Measured: one year
Secondary outcomes (1)
To measure success rate of fetal heart rate data across different stages of pregnancy
Success rate will be presented in percentage.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startSep 2015
- Primary completion8 Nov 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk PregnancyStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habiba Kapaya, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627482
- Sponsor's protocol ID
- STH18636
- Status last verified
- Apr 2017
- First submitted
- 21 Nov 2015
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kapaya H, Broughton-Pipkin F, Hayes-Gill B, Loughna PV. Smoking in pregnancy affects the fetal heart: possible links to future cardiovascular disease. J Matern Fetal Neonatal Med. 2015;28(14):1664-8. doi: 10.3109/14767058.2014.964202. Epub 2014 Dec 15.
PubMed 25212975
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Employing Ambulatory Fetal Heart Rate Monitoring in Small for Gestational Age Fetuses at Risk of Stillbirth.
- ClinicalTrials.gov ID
- NCT02627482
- Acronym / sponsor ID
- STH18636
- Conditions
- High Risk Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 8 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 11 Dec 2015 (estimated)
- 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.
Most babies who measure small during pregnancy are born healthy. However, some are small because they are not growing as expected, usually because the placenta (the baby's 'life support' system) is not working properly. These babies are at greatly increased risk of dying before birth, and need to be delivered before they become poorly.
Scans and electronic heartrate monitoring are currently used to monitor these babies. But they can only be used for short periods and don't always provide enough information to show when to deliver the baby.
A small light monitor has been developed that safely records the baby's heart rate for up to 16hrs by measuring electrical activity through sticky patches on the mum's skin (like a normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the heart rate over a longer time may help with decisions about the timing of the delivery and could prevent stillbirth, the aim of our future study. This will include large numbers of women carrying small babies. Before the investigators can do this the investigators need to know whether:
- Wearing the monitor for 16hrs is practical and acceptable to pregnant women
- The monitor can provide useful information on the baby's heart rate at different stages of pregnancy.
Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on two occasions, for 16hrs each time. The women will describe what they think about wearing the monitor by completing questionnaires.
The data from the monitor will be downloaded and compared with the woman's medical notes after the participant has delivered her baby. Results from this study will be publicised and will help with the design of the investigators future study into the usefulness of this monitor.
Detailed description
Study design:
The study has been designed as a prospective, non randomised, single centre feasibility study to determine the acceptability and reliability of the Monica AN24 device, as a method of long-term fetal heart rate (FHR) monitoring on more than one occasion in the antenatal period.
Objectives of the study:
The proposed feasibility study aims to:
- Assess the recruitment rates and practicality of the study design and protocol.
- Evaluate the acceptability to participants of wearing the device for overnight FHR monitoring on two occasions in pregnancy.
- Measure the success rate of generating good quality overnight FHR data and identify any limitations of the technique.
- Determine response rates to questionnaires
Recruitment The investigators will recruit women from 28 completed weeks of gestation. The investigators will study each participant on two occasions (2-4 weeks apart). Being a feasibility study FHR data obtained during these experiments will not be employed in the routine clinical care of study participants whose care will follow standard patterns of surveillance employed at the Jessop Wing Hospital (JW), Sheffield.
Statistical analysis:
As this is a feasibility study the investigators will employ mainly descriptive analysis. The investigators will report rates of consent, recruitment and acceptability of wearing the AN24 device on two occasions. The investigators shall also report the rates and duration of obtaining valid FHR data when the device is worn. The feasibility and FHR outcome measures will be summarised and will inform design for future definitive studies.
Future work and clinical impact of this research:
The investigators believe that incorporating ambulatory FHR monitoring to the current methods employed to monitor SGA could predict and prevent stillbirth. This is the overarching aim of our future definitive multicentre study which will require collection of longterm FHR data at different stages of pregnancy from at least 500 women carrying small babies. Data captured from our feasibility study will inform the design of our main study and ensure that our design is robust and that all the potential issues identified in the feasibility study have been addressed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Investigators will recruit 30 women with a singleton pregnancy (no congenital abnormality) and a customised birth weight ratio of less than 10th centile on ultrasound from the small baby clinic, which is provided at the Fetomaternal Unit (FMU) at the Jessop Wing (JW) Hospital, Sheffield. Each participant will be studied on 2 occasions, 2 to 4weeks apart at their routine hospital visit for serial ultrasound scans.
Key inclusion criteria (1 listed)
- All women with singleton pregnancy from 28 completed weeks of gestation, suspected to carry small for gestational age (SGA) fetus on ultrasound scan but with no known congenital abnormality will be eligible for inclusion in the study if they agree.
Key exclusion criteria (4 listed)
- Evidence of a major fetal malformation on ultrasound scan
- Clinical suspicion of labour
- Multiple pregnancy
- Involved in another study using a device or medicinal product
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 |
|---|---|---|
| Fetal heart rate monitor (Monica AN24)The AN24 is a portable, battery powered device, developed in the UK and designed to monitor passively an unborn baby in the antenatal period. The device is CE marked and is attached via a cable assembly which in turn attaches to five standard disposable electrodes placed on the abdomen of a pregnant woman. It is intended for ambulatory use in either the home or hospital environment. The AN24 has had rigorous checks in the UK and has been used in many European countries. No hazards have been identified that could compromise the safety of, or cause harm to the fetus or the mother. The only potential issue identified is a local reaction under the electrodes. Nonetheless, the electrodes used are the standard disposable ECG electrodes, used routinely for adult ECG measurements. | Device | – |
Primary outcome
To assess recruitment rate to the study on first invitation
Time frame: one year
To estimate proportion of recruited women who demonstrate willingness to wear the monitor two times
Time frame: one year
In light of investigator's previous work, no problems are anticipated in achieving 30 recruits in a year. However, study would be deemed successful if at least 80% of participants wear the monitor on second occasion and complete the study
1 secondary outcome
To measure success rate of fetal heart rate data across different stages of pregnancy
Time frame: one year
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 1 May 2017.
- Background: PubMed 25212975Kapaya H, Broughton-Pipkin F, Hayes-Gill B, Loughna PV. Smoking in pregnancy affects the fetal heart: possible links to future cardiovascular disease. J Matern Fetal Neonatal Med. 2015;28(14):1664-8. doi: 10.3109/14767058.2014.964202. Epub 2014 Dec 15.
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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 High Risk Pregnancy, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 1 inclusion and 4 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 1 May 2017. 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?
To assess recruitment rate to the study on first invitation (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627482, which also lists 1 linked publication.
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 1 May 2017.