ISRCTN27626961
Completed
未知
Magnetic resonance imaging to enhance the diagnosis of fetal developmental brain abnormalities in utero
Sheffield Teaching Hospitals NHS Foundation Trust (UK)0 sites570 target enrollmentMarch 14, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust (UK)
- Enrollment
- 570
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31538569 (added 23/09/2019)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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