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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 September 2017 |
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Main ID: |
ISRCTN12983949 |
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Date of registration:
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15/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pre-conception care for women with diabetes
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Scientific title:
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Pre-conception care for women with type 1 or type 2 diabetes: what are the facilitators and barriers to uptake? |
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Date of first enrolment:
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30/01/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12983949 |
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Study type:
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Observational |
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Study design:
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Observational multicentre study (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sarah
Earle |
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Address:
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Horlock Building
Walton Hall
The Open University
MK7 6AA
Milton Keynes
United Kingdom |
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Telephone:
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+44 (0)1908 654 260 |
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Email:
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sarah.earle@open.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. White British women and Pakistani women (whose preferred language is Urdu), with pre-existing Type 1 and Type 2 diabetes of childbearing age between 16 and 45 years inclusive
2. Staff and stakeholders who are involved in caring for women with diabetes of reproductive age and/or the delivery of pre-conception care
Exclusion criteria: 1. Women with diagnosed mental health issues
2. Women <16 and >45 years
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Diabetes in pregnancy
Pregnancy and Childbirth
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Intervention(s)
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The proposed study adopts a qualitative mixed-methods approach designed to explore the two key research questions, namely, to understand why women with diabetes of childbearing age do/do not access pre-conception care, and to elicit the views of staff and stakeholders on this and on future provision of this service. A better understanding of the views of women, and of the relevant staff and stakeholders, is needed in order to inform service design and delivery. The use of qualitative methods is best placed to explore views on the provision of, and the facilitators and barriers to, the uptake of pre-conception care. A qualitative mixed-methods design will be used to ensure that the views of service users are at the centre of the research. This design will also allow meaningful and nuanced data to emerge that reflects the views of services users, staff and stakeholders and can be used to understand how pre-conception care could be provided to optimise uptake and outcomes.
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Primary Outcome(s)
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1. To understand why women with diabetes of childbearing age do, or do not, access pre-conception care, with a view to informing services
2. To investigate the views of staff and stakeholders to explore existing and future provision of pre-conception care
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Secondary Outcome(s)
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No secondary outcome measures
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Secondary ID(s)
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HTA 12/185/14
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Source(s) of Monetary Support
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Health Technology Assessment Programme
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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