MERIDIAN Add-On Study
The MERIDIAN Add-On study is now closed for recruitment.
The study is recruiting at 14 of the existing MERIDIAN sites, along with PIC (Participant Identification Centre) sites at St George's Hospital, London and Liverpool Women's Hospital.
Participants will be informed about the study when attending a fetal medicine clinic appointment for an antenatal ultrasound scan with a relevant health professional (e.g. fetal medicine specialist or sonographer) at the MERIDIAN sites listed above.
The aim of the project is to find out how and when MRI should be used to improve the information available to parents before birth about the health of their baby. In this part of the project we are looking at babies whose brains are developing normally. We are going to see if ultrasound and MRI give the same information about brain development. The research is set up to look at brain development only and any investigations used by us focus on this area alone.
There are two elements to the study, which is looking at those babies whose brains are developing normally.
The first (A1) is looking at babies whose brains are developing normally based on ultrasound scan by a feto-maternal expert.
The second (A2) is looking at babies whose brains are developing normally but have some other form of non-brain abnormality based on ultrasound scan by a feto-maternal expert.
Both studies A1 and A2 plan to recruit 200 women who have had a detailed ultrasound scan by a feto-maternal expert, showing no problem with the development of their baby's brain.
Participants will be identified during a fetal medicine clinic visit at a participating MERIDIAN site. Participants will then have a screening telephone call to assess their eligibility for the study and to arrange a date for the MRI at the Academic Unit of Radiology in Sheffield. There will be time for further discussion and questions about the study on arrival at the Unit in Sheffield and written consent will be taken. The scan(s) will then be undertaken, looking at the brain development of the baby only.
The study has also been promoted through local media and word of mouth; this means that pregnant women can self-refer to the study by contacting the study team on the details below. They will receive a screening call to assess eligibility and will need to confirm that they have been informed that their baby’s brain is developing normally based on their detailed anomaly ultrasound scan.
If you would like further information or are interested in taking part in the study then please phone 0114 2159595 or email MERIDIAN@sheffield.ac.uk.
Funder: This project is funded by the NIHR Health Technology Assessment (HTA) programme (project number 09/06/01), with the support of the Comprehensive Clinical Research Network. A full project report will be published in Health Technology Assessment. Any views or opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.