Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15640 participants
OBSERVATIONAL
2018-04-25
2021-08-31
Brief Summary
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Detailed Description
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Women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing.
The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (\>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing.
Exclusion Criteria
* Unable to understand written or verbal English which would preclude them from understanding the study
0 Months
4 Months
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Locations
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Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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OVG 2017/09
Identifier Type: -
Identifier Source: org_study_id
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