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

NCT05164432 | Unknown

• 1 other identifier: 1121988
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Preterm Birth Complication

Outcome Measures

Primary Outcomes (2)

• Number of participants with chorioamnionitis

  Chorioamnionitis will be diagnosed on placental histology

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

• Neonatal morbidity

  A composite neonatal adverse outcome will be created

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

Secondary Outcomes (1)

• Individual adverse neonatal outcomes

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

Study Arms (2)

High risk of preterm birth

EXPERIMENTAL

Women at high risk of preterm birth

Diagnostic Test: MRI scan

Women with low risk pregnancies

ACTIVE COMPARATOR

Women with uncomplicated pregnancies anticipated to deliver at term

Diagnostic Test: MRI scan

Interventions

MRI scan DIAGNOSTIC_TEST

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

High risk of preterm birth; Women with low risk pregnancies

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Pregnant women will be recruited
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Massachusetts Institute of Technology: collaborator
• Boston Children's Hospital: collaborator
• Phoenix Children's Hospital: collaborator

Study Sites (1)

St Thomas' Hospital, King's College London

London, Greater London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Lisa Story, MD PhD

CONTACT

020 7188 7083; lisa.story@kcl.ac.uk

Reza Razavi, MD PhD

CONTACT

02078483224; reza.razavi@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of women will be recruited those at high risk of preterm birth and those who have uncomplicated pregnancies

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 20, 2021
• Study Start: December 1, 2021
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Data is suitable for sharing in anonymised form. It is intended that the data will be made available on completion of data collection and publication of findings.
• Access Criteria: Data can be used for academic purposes. Users are bound by a data sharing agreement which does not allow the commercial use of the data and sets out their responsibilities to acknowledge publications and funding associated with the data, not attempting to de-anonymise and identify any subjects as well as their duty to inform the research team of any relevant observations and results.

Locations

GB (1)