Pregnancy and Neurodevelopment Study_v1
Research type
Research Study
Full title
The ‘Pregnancy and Neurodevelopment’ Study
IRAS ID
334168
Contact name
Simon Baron-Cohen
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (joint sponsors)
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
The aim of the study is to investigate the association between sex differences in pregnancy and early neurodevelopment.
Participating mothers will be recruited prospectively, at a prenatal appointment in a maternity ward in any of the affiliated NHS sites, or retrospectively after giving birth, provided they have previously agreed to be contacted for research. This retrospective recruitment will be specific to the 'Tommy's' Research Centre at the University of Manchester and the affiliated maternity wards in the city, where women are routinely asked for their interest in research, as well as for their family history of neurodevelopmental conditions such as autism and ADHD.
All participants will be asked to consent to the sending of placental tissue and cord blood to the Autism Research Centre of the University of Cambrdige, and the linking of these samples to specific items from their clinical and family history (e.g. having themselves or a previous child diagnosed with a neurodevelopmental condition such as autism or ADHD).
The cord blood will be analysed for sex steroid levels. The placental tissue will be analysed for morphology and using genetic sequencing, in order to study which genes are expressed and which are silenced. This will be done in collaboration with specialists at the University of Exeter. The results will be analysed by researchers, who will study for group differences, based on the sex of the child and based on the family history for neurodevelopmental conditions such as autism or ADHD.
In addition, participants will be asked to consent to be contacted for the first two years after delivery, in order to reply to questionnaires about the child (e.g., on first words, motor milestones, behaviour etc). This follow-up will be optional, will be conducted remotely via online questionnaires and will not be diagnostic but rather descriptive of the child's development.REC name
East of England - Essex Research Ethics Committee
REC reference
25/EE/0027
Date of REC Opinion
10 Apr 2025
REC opinion
Further Information Favourable Opinion