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Preterm Birth ComplicationNCT05164432

Prediction of Adverse Outcome Using Fetal MRI in Pregnancies at Risk of Preterm Birth

A study testing MRI scan in people with Preterm Birth Complication, run by King's College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1.4% of babies have a very premature birth (PTB) (less than 32 weeks of pregnancy). This can result in severe life-long complications including cerebral palsy, learning and behavioural difficulties and breathing problems. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Birth Complication
What is being tested?
MRI scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteUnited Kingdom
Study dates
1 Dec 2021to 1 Nov 2025
Phase
Interventional
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 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • pregnant women with uncomplicated pregnancies 16-42 weeks pregnant OR
  • pregnant women at high risk of preterm birth before 32 weeks gestation

Who cannot join

  • inability to give informed consent
  • multiple pregnancy
  • gestational diabetes
  • pre-eclampsia
  • fetuses known to have chromosomal or fetal abnormalities
  • a recently sited maternal metallic implant, claustrophobia.

Trial locations and contacts

1 site in 1 country.

Lisa Story, MD PhD contact

020 7188 7083

lisa.story@kcl.ac.uk

Reza Razavi, MD PhD contact

02078483224

reza.razavi@kcl.ac.uk

United Kingdom1 site, 1 recruiting
  • St Thomas' Hospital, King's College London

    London, Greater London, SE1 7EH

    Lisa Story, MD PhD, 020 7188 7083, lisa.story@kcl.ac.uk

    Jana Hutter, PhD, 020 7188 7083, jana.hutter@kcl.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Individualised Risk Prediction of Adverse Neonatal Outcome in Pregnancies That Deliver Preterm Using Advanced MRI Techniques and Machine Learning

1.4% of babies have a very premature birth (PTB) (less than 32 weeks of pregnancy). This can result in severe life-long complications including cerebral palsy, learning and behavioural difficulties and breathing problems. This has significant cost implications for the NHS, education services and immeasurable human costs for the child and their family.

Early delivery may result from maternal infection or poor attachment of the placenta to the womb, which may also cause abnormal brain and lung development. Even where obvious signs of infection are not present in the mother, subtle infection is often present in the baby. Currently there is no test routinely used to see if there is an infection of the baby inside the womb, and it is unknown how the placenta develops in babies that subsequently deliver preterm.

Read more

Using MRI, the investigators will assess the baby's thymus and placenta for signs of infection and assess how the lungs and brain are developing whilst still in the womb. Machine learning techniques, where computers analyze all the results together, will then be used to see if these scans can identify babies that do poorly after birth.

137 pregnant women at high risk of PTB (between 16-32 weeks of pregnancy) and 183 women with uncomplicated pregnancies will be invited to participate.

Women will have an MRI scan of the fetus assessing the lung, brain, thymus and placenta. Where high risk women do not deliver, repeat imaging will be offered every two weeks (maximum 3).

After birth the investigators will see if infection was present by analysing the placenta under a microscope, and see how the baby does. All the information from scans and after birth will be put into a computer, to predict which babies do poorly after birth. Health records of the child will be accessed up to two years of age.

Read the detailed description

1.4% of babies have a very premature birth (PTB) (less than 32 weeks of pregnancy). This can result in severe life-long complications including cerebral palsy, learning and behavioural difficulties and breathing problems. Besides immeasurable human costs for the baby and family this also has significant cost implications for the NHS.

Infection may cause both early delivery and subsequent abnormal brain and lung development. Where obvious signs of infection are not present in the mother, subtle infection is often present in the unborn baby. Currently there is no test routinely used to see if there is an infection of the baby in the womb.

Fetal Magnetic Resonance Imaging (MRI), already used in clinical practice, can produce very clear images of the baby's brain and lungs. It can also assess blood flow and structure in detail, as well as overall size. The investigators already have data, which shows areas of the brain and lungs are smaller in babies that subsequently deliver very preterm, indicating factors that drive preterm birth may already be affecting how the baby develops in the womb.

MRI can also give information regarding infection in the fetus by measuring an organ in the neck (the thymus) vital to the baby's immune system and by scanning the placenta. The investigators have new data that suggests that these methods could help pick up infection. Women who have previously undergone preterm birth have helped shape this study.

Aims The investigators want to ascertain if it is possible to predict which babies are likely to develop serious complications after preterm birth. Using MRI, the thymus and placenta will be assessed for signs of infection and how the lungs and brain are developing whilst still in the womb will be monitored. The investigators will evaluate if these scans accurately identify the babies that do poorly after birth.

Study Design 75 pregnant women at high risk of PTB (between 16- 32 weeks of pregnancy) and 100 women with uncomplicated pregnancies will be invited to participate.

Women will be identified as high-risk if:

  1. they have no symptoms but are, attending the Preterm Surveillance Clinic at St Thomas's Hospital, with risk factors for PTB (a previous premature delivery or surgery to the neck of the womb (cervix)) and are likely to deliver early, which we can pick up by seeing if the cervix has already shortened, and by doing a vaginal swab test.
  2. they have lost the fluid (waters) around the baby
  3. the cervix has opened before 24 weeks These women will have an MRI scan of the fetal lung, brain, thymus and placenta. Repeat imaging will be offered every two weeks (maximum of three scans).

After birth the investigators will see if infection is present by analysing the umbilical cord blood and looking at the placenta under a microscope. Information about complications the babies have until they leave hospital will be collected.

All of this information, as well as from scans from healthy pregnant women involved in other research studies both in this country and from abroad, will be combined in a new test, using 'machine learning', which involves computers analysing the data to see if babies most likely to have problems after birth can be identified. Results will be presented in scientific papers, at conferences and through social media.

If the test works, the next step would be to find out when the best time is to deliver the baby; this may be sooner if the fetus is known to have an infection. The appropriate timing of existing treatments to prevent brain and lung injury may also be facilitated with more studies in the future.

Being tested
MRI scan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI scanDiagnostic test

    Women will have an MRI scan during pregnancy to evaluate the fetus and placenta

Study groups in NCT05164432
Study groupRoleWhat they receive
High risk of preterm birthExperimentalWomen at high risk of preterm birth
Receives: Diagnostic Test: MRI scan
Women with low risk pregnanciesActive comparatorWomen with uncomplicated pregnancies anticipated to deliver at term
Receives: Diagnostic Test: MRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with chorioamnionitis

    Chorioamnionitis will be diagnosed on placental histology

    Measured: After delivery (within approximately three months of recruitment depending on the gestation at delivery)

  2. Neonatal morbidity

    A composite neonatal adverse outcome will be created

    Measured: Neonatal period post delivery (up to approximately seven months after recruitment depending on the gestation at delivery)

Secondary outcomes (1)
  1. Individual adverse neonatal outcomes

    Specific neurological, respiratory, GI and individual systems adverse outcomes for the neonate

    Measured: Neonatal period post delivery (up to approximately seven months after recruitment depending on the gestation at delivery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start1 Dec 2021
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Two groups of women will be recruited those at high risk of preterm birth and those who have uncomplicated pregnancies
Masking
None (open label)
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164432
Sponsor's protocol ID
1121988
Status last verified
Oct 2023
First submitted
15 Nov 2021
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data will be shared with other researchers

Questions about this trial

What is this clinical trial studying?

A study testing MRI scan in people with Preterm Birth Complication, run by King's College London 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lisa Story, MD PhD (020 7188 7083, lisa.story@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with chorioamnionitis (time frame: After delivery (within approximately three months of recruitment depending on the gestation at delivery)). 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?
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 26 Oct 2023.

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