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

Sheffield Teaching Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 570 人开始时间: 2011年3月14日最近更新: 2019年10月29日

试验速览

•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.

•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 If they were withdrawn at any stage of MERIDIAN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

发起方

Sheffield Teaching Hospitals NHS Foundation Trust (UK)