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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: t
View:

• pregnant women with uncomplicated pregnancies 16-42 weeks pregnant OR

• pregnant women at high risk of preterm birth before 32 weeks gestation

Locations
Other Locations
United Kingdom
St Thomas' Hospital, King's College London
RECRUITING
London
Contact Information
Primary
Lisa Story, MD PhD
lisa.story@kcl.ac.uk
020 7188 7083
Backup
Reza Razavi, MD PhD
reza.razavi@kcl.ac.uk
02078483224
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 175
Treatments
Experimental: High risk of preterm birth
Women at high risk of preterm birth
Active_comparator: Women with low risk pregnancies
Women with uncomplicated pregnancies anticipated to deliver at term
Related Therapeutic Areas
Sponsors
Collaborators: Phoenix Children's Hospital, Boston Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, Massachusetts Institute of Technology, National Institute for Health Research, United Kingdom
Leads: King's College London

This content was sourced from clinicaltrials.gov