The Neurodevelopmental outcome of Complicated Twin Pregnancies

• Research type

  Research Study

• Full title

  Twin pregnancies With complications; Impact on Neurodevelopment Study (TWINS)

• IRAS ID

  202436

• Contact name

  Asma Khalil

• Contact email

  Asma.Khalil@stgeorges.nhs.uk

• Sponsor organisation

  St George's University Hospital NHS Foundation Trust

• Duration of Study in the UK

  2 years, 4 months, 31 days

• Research summary

  Complicated identical twin pregnancies are at risk of neurodevelopmental delay (disability). The incidence of neurodevelopmental delay in these pregnancies and the risk 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 twin pregnancy. 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. All eligible women will be identified by staff from the ultrasound database at the Fetal Medicine Unit and the maternity records. All women 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. Age & Stage Questionnaire (ASQ) will be sent to the mothers using a mail-out procedure. The ASQ is a parent-completed questionnaire which contains 30 developmental items that are divided into five areas: communication, gross motor, fine motor, problem-solving and personal–social. 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

  North West - Preston Research Ethics Committee

• REC reference

  16/NW/0194

• Date of REC Opinion

  29 Mar 2016

• REC opinion

  Unfavourable Opinion