Does magnetic resonance imaging (MRI) improve the accuracy of diagnosis of brain abnormalities in the unborn fetus?

Magnetic resonance imaging to enhance the diagnosis of fetal developmental brain abnormalities in utero

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN27626961

Enrollment

750

Registered

2011-03-14

Start date

2011-04-01

Completion date

Unknown

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital disorders Pregnancy and Childbirth

Interventions

Initial study: MERIDIAN is a multicentre study recruiting from 13 sites within the UK incorporating a wide geographic and socioeconomic base. Participants will be recruited by a feta

participants have the option to participate in project 1 or project 1 and 2. Project 3 does not require any participant involvement. Consent for projects 1 and 2 will be obtained via post.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Initial study: 1. Participant is in the late second or third trimester of pregnancy (18 weeks gestational age and onwards) 2. Participant is thought to be carrying a fetus with a developmental brain abnormality following detailed specialist ultrasound examination 3. Participant has a singleton or multifetal pregnancy Follow-up study: 1. Participated in MERIDIAN and has a surviving child aged 2 years old or more* 2. Underwent an iuMR scan during pregnancy as part of MERIDIAN *If the child is no longer alive then data will be collected and recorded on date of death and cause of death. No contact will be made with the family. Children who are over 38 months (term corrected) will not be eligible for a developmental assessment but will be included in project 1 (case note review), additional data will only be collected up until the child was 42 months.

Exclusion criteria

Exclusion criteria: Initial study: 1. Participant is unable to give informed consent. 2. Participant has a cardiac pacemaker, intraorbital metallic foreign body or recent surgery with metallic sutures or implant 3. Participant has previously experienced or is likely to suffer severe anxiety or claustrophobia in relation to MR imaging examination 4. Participant is unable or unwilling to travel to Manchester, Edinburgh, Birmingham, Leeds, Newcastle or Sheffield for specialist MR imaging 5. Participant is unable to understand English (except where satisfactory translation services are available) 6. Participant is under the age of 16 years Follow-up study: 1. If the child born from MERIDIAN is no longer alive (*see above) 2. If the child is no longer in the care of the biological mother who consented to the original MERIDIAN study 3. Is unable to give informed consent 4. Is unable to understand English (except where another parent/guardian of the child can translate and provide consent) 5. If they were withdrawn at any stage of MERIDIAN 6. If they did not attend for fetal MR as part of MERIDIAN

Design outcomes

Primary

Measure	Time frame
Initial study: 1. Absolute diagnostic accuracy of MRI as assessed by percentage of cases where in utero MR diagnosis agrees with post-mortem autopsy/MRI or postnatal imaging 2. Absolute diagnostic accuracy of ultrasound scan as assessed by percentage of cases where ultrasound diagnosis at the time of referral for MRI agrees with post-mortem autopsy/MRI or postnatal imaging. Agreement between prenatal diagnosis and outcome diagnosis will be judged independently by two fetal medicine experts and a third expert will arbitrate if there is a discrepancy in opinion. Follow-up study: 1. Project 1 The primary outcome measure will be a refined estimate of diagnostic accuracy of in utero MR compared to antenatal US. This will be measured by: 1.1. Measurement of diagnostic accuracy of antenatal US alone (i.e. prior to in utero MR) relative to updated reference diagnosis at 2-3 years of age (postnatal imaging or post-mortem examination) 1.2. Measurement of diagnostic accuracy of in utero MR (following antenatal US) relative to the updated reference diagnosis at 2-3 years of age (postnatal imaging or post-mortem examination). 2. Project 2 The primary outcome measure will be to quantify the value of prognoses based on MR and USS by: 2.1. Assessing the concordance between severe neurodevelopmental impairment (defined by BSID <70 on either index) and poor prognosis, based on MR and on USS 2.2. Comparing the relative prognostic accuracy of USS and MR 3. Project 3 We will assess the clinical significance of isolated, mild ventriculomegaly through: 3.1. Identification of all isolated, mild ventriculomegaly cases diagnosed on in utero MR in the MERIDIAN cohort and defining their developmental outcome at 2-3 years 3.2. Comparison of developmental ou	—

Measure

Time frame

Initial study: 1. Absolute diagnostic accuracy of MRI as assessed by percentage of cases where in utero MR diagnosis agrees with post-mortem autopsy/MRI or postnatal imaging 2. Absolute diagnostic accuracy of ultrasound scan as assessed by percentage of cases where ultrasound diagnosis at the time of referral for MRI agrees with post-mortem autopsy/MRI or postnatal imaging. Agreement between prenatal diagnosis and outcome diagnosis will be judged independently by two fetal medicine experts and a third expert will arbitrate if there is a discrepancy in opinion. Follow-up study: 1. Project 1 The primary outcome measure will be a refined estimate of diagnostic accuracy of in utero MR compared to antenatal US. This will be measured by: 1.1. Measurement of diagnostic accuracy of antenatal US alone (i.e. prior to in utero MR) relative to updated reference diagnosis at 2-3 years of age (postnatal imaging or post-mortem examination) 1.2. Measurement of diagnostic accuracy of in utero MR (following antenatal US) relative to the updated reference diagnosis at 2-3 years of age (postnatal imaging or post-mortem examination). 2. Project 2 The primary outcome measure will be to quantify the value of prognoses based on MR and USS by: 2.1. Assessing the concordance between severe neurodevelopmental impairment (defined by BSID <70 on either index) and poor prognosis, based on MR and on USS 2.2. Comparing the relative prognostic accuracy of USS and MR 3. Project 3 We will assess the clinical significance of isolated, mild ventriculomegaly through: 3.1. Identification of all isolated, mild ventriculomegaly cases diagnosed on in utero MR in the MERIDIAN cohort and defining their developmental outcome at 2-3 years 3.2. Comparison of developmental ou

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Secondary

Measure	Time frame
Initial study: 1. Effect of including the MRI scan on diagnostic confidence - Change in diagnostic confidence will be measured before and after the scan as assessed by a 5 point likert scale 2. Effect of including the MRI scan on prognosis - Change in prognosis will be measured before and after the MRI scan as assessed by a 4 point categorical scale (poor - less than 50% chance of normal neuro-developmental outcome, intermediate - 50-90% chance of normal outcome, favourable - greater than 90% chance of normal outcome, normal - no abnormality found after detailed fetal medicine investigation) 3. Effect of including MRI scan on management - Change in management will be measured before and after the MRI scan as asssessed by a 2 point categorical scale. This scale will record whether termination of pregancy was discussed on the basis of poor neuro-developmental prognosis 4. A sociological study to include - survey questions to assess participants levels of anxiety and depression at stages of the care pathway (Hospital Anxiety and Depression Scale - HADS), participant views on the care package they have encountered and in-depth interviews on a subsample of participants and involved health professionals 5. A health economics study will be completed to assess the cost effectiveness of including MRI scans Follow-up study: Project 2 1. Qualitative assessment of the cases for which the USS prognosis and MR prognosis differed, in relation specifically to the original diagnoses. Prognosis was measured on a 5 point categorical scale (poor – less than 50% chance of normal neurodevelopmental outcome, intermediate – 50-90% of normal outcome, favourable – greater than 90% chance of normal outcome, normal – no abnormality found, or unknown). 2. The concordance in the subgroup of children for which the MR scan was performed within 24 weeks.	—

Measure

Time frame

Initial study: 1. Effect of including the MRI scan on diagnostic confidence - Change in diagnostic confidence will be measured before and after the scan as assessed by a 5 point likert scale 2. Effect of including the MRI scan on prognosis - Change in prognosis will be measured before and after the MRI scan as assessed by a 4 point categorical scale (poor - less than 50% chance of normal neuro-developmental outcome, intermediate - 50-90% chance of normal outcome, favourable - greater than 90% chance of normal outcome, normal - no abnormality found after detailed fetal medicine investigation) 3. Effect of including MRI scan on management - Change in management will be measured before and after the MRI scan as asssessed by a 2 point categorical scale. This scale will record whether termination of pregancy was discussed on the basis of poor neuro-developmental prognosis 4. A sociological study to include - survey questions to assess participants levels of anxiety and depression at stages of the care pathway (Hospital Anxiety and Depression Scale - HADS), participant views on the care package they have encountered and in-depth interviews on a subsample of participants and involved health professionals 5. A health economics study will be completed to assess the cost effectiveness of including MRI scans Follow-up study: Project 2 1. Qualitative assessment of the cases for which the USS prognosis and MR prognosis differed, in relation specifically to the original diagnoses. Prognosis was measured on a 5 point categorical scale (poor – less than 50% chance of normal neurodevelopmental outcome, intermediate – 50-90% of normal outcome, favourable – greater than 90% chance of normal outcome, normal – no abnormality found, or unknown). 2. The concordance in the subgroup of children for which the MR scan was performed within 24 weeks.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026