Extrait

Background and study aims: Ultrasound scanning is routinely used during pregnancy to identify babies who appear to have abnormal brain development; no medical test is perfect however, and the information provided by ultrasound is occasionally incomplete or inaccurate. The purpose of the initial study was to find out if magnetic resonance imaging (MRI) improves the accuracy of diagnosis of brain abnormalities. Between July 2011 and August 2014 the study recruited over 900 pregnant women whose ultrasound showed abnormal development of the baby’s brain. Following on from this, MERIDIAN was extended to incorporate additional follow-up of its participants, which allows us to update and improve the MERIDIAN primary outcome data using updated postnatal information available when the children are aged 2-3 years and to refine the information given to pregnant women by collecting developmental outcome data on children in MERIDIAN. Who can participate? Pregnant women over the age of 16 who were carrying a baby with a suspected brain abnormality following a specialist ultrasound examination. Both single and multifetal pregnancies were eligible and all participants were at least 18 weeks gestational age. All surviving children from the MERIDIAN cohort, whose mother underwent MR imaging during her pregnancy will be invited to participate in the follow up study. What does the study involve? All pregnant women recruited to the study are invited for an MR scan and the information from the scan then used by their doctor to help with their medical care. MRI results are compared with the results of scans and other tests performed after delivery. We also look at whether using MRI changes the counselling and information about the baby’s development given to the women, and whether this extra information is helpful for participants in how they come to their decision about continuing with the pregnancy or not. The women and the health professionals that care for them are asked by questionnaire and interview for their opinions about MRI and how helpful it is. Finally, the cost of using MRI is estimated and evaluated against the number of times it has a direct impact on antenatal counselling. The follow up study involves a medical case note review in which the research team review the child’s medical records to collect information about the child’s development, postnatal diagnoses and postnatal imaging or investigations until the age of 2-3 years. Participants are also invited to participate in a development assessment called the Bayley’s Scale of Infant Development. The results from the assessments allow us to classify the developmental status of the child. This is compared to the prognosis given based on antenatal ultrasound and MRI. What are the possible benefits and risks of participating? Potential benefits for study participants included the possibility of additional or more accurate diagnostic information relevant to their pregnancy, additional clinical contact (both with staff at the MR centre and also with clinical staff at the referring centre) and the chance to view and discuss the MR images acquired with a relevant health professional. The risks to the pregnant woman in performing in utero MR are exceptionally small. The greatest risk to the woman was from the recognised general contraindications to MR examination (e.g. cardiac pacemaker). The absolute risk to the fetus of performing MR imaging in the second and third trimesters is not certain, but no definite health risks are currently known. The potential benefits of participating in the follow up study are that they may gain additional information about their child's development. There may also be opportunity for participants to be signposted towards additional support where required. A potential risk to participation is that occasionally, children become tired or are unwilling to take part in the developmental assessment. The assessment will always be conducted with parents present which is usually enough to put the child at ease and most children enjoy completing the tasks. There is a small chance that we might identify a previously unrecognised developmental problem. This would be very unusual at the 2-3 year age window we are using. Where this occurs we will speak to parents about future actions. Where is the study run from? The work is centred at the Academic Unit of Radiology, University of Sheffield. Women were recruited from 15 specialist Fetal Medicine Units into the initial study. These units cover a large area of England, Scotland and Northern Ireland. MRI scans were carried out in Sheffield, Newcastle, Leeds, Birmingham, Nottingham QMC and Belfast. For the follow up study participants will be approached by the hospital site in which they were first recruited to the initial MERIDIAN study. When is the study starting and how long is it expected to run for? April 2011 to November 2017. . Who is funding the study? NIHR - Health Technology Assessment Programme - HTA (UK) Who is the main contact? Professor Paul Griffiths [email protected]

Critère d'inclusion

• Congenital Disorders

Liens

• isrctn
• ictrp