Twins With complications: Impact on Neurodevelopment
Research type
Research Study
Full title
Twin pregnancies With complications: Impact on Neurodevelopment Study via Registry Follow up (TWINS-RF)
IRAS ID
202436
Contact name
Asma Khalil
Contact email
Sponsor organisation
St George's University Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
When identical twins share a placenta (monochorionic) they are at increased risk of neurodevelopmental delay (disability), especially when there are problems in the shared blood supply in the placenta (this includes conditions like twin-to-twin transfusion syndrome, twin anaemia polycythaemia sequence and selective fetal growth restriction). The incidence of neurodevelopmental delay in the surviving children of these pregnancies and the factors associated with worse long-term neurodevelopmental outcome are yet to be established.
The primary research objective is to establish the incidence of adverse neurodevelopment in normal and complicated monochorionic twin pregnancies. We plan to recruit pregnancies where the delivery occurred at least one year ago. When possible, the controls will be matched to the gestational age at delivery.
Eligible women will be identified by research staff from the TAMBA multiple pregnancy registry. All women identified from the registry will be sent an information leaflet about the study and invited to take part. Those who agree to take part will be asked to sign a consent form.
Participants will be asked to complete the Age & Stage Questionnaire 3rd edition (ASQ-3) in respect of their child/children. The ASQ-3 is a parent-completed questionnaire which contains 30 developmental items divided into five areas: communication, gross motor, fine motor, problem-solving and personal–social. This is a validated screening tool for identifying possible developmental delay.
The assessment of responses will be performed by researchers who are blinded to whether this pregnancy was complicated or not, in order to avoid potential investigators’ bias. A follow-up telephone call will be made a few days later to ensure receipt and to address any question the parents might have. If the questionnaire is not returned within two weeks, a second questionnaire will be sent by certified mail and a second telephone call will be made to remind the parents to return the questionnaire
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/0295
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion