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ISRCTN
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ISRCTN76982667
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ClinicalTrials.gov identifier
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Public title
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A cluster randomised controlled trial of selective consent for the second trimester ultrasound scan
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Scientific title
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Acronym
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USS & You
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Serial number at source
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N/A
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Study hypothesis
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Women given detailed information about the content and effectiveness of the second trimester fetal abnormality scan would experience no additional anxiety after their scan than women given standard information and care.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Second trimester ultrasound scan
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Participants - inclusion criteria
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1. Pregnant women booked at the Royal Victoria Infirmary (RVI) attending for a 'routine' second trimester anomaly scan
2. Aged 16-50
3. Able to communicate verbally in English
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Participants - exclusion criteria
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1. Known twin pregnancy
2. Women who have been given a risk positive result from an earlier scan
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Anticipated start date
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01/01/2002
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Anticipated end date
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20/11/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1466
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Interventions
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1. A structured face to face discussion with a research midwife or research sonographer about the purpose of and effectiveness of the second trimester fetal anomaly scan followed by the opportunity to accept or decline 5 separate components of the procedure
2. Standard information and care
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Primary outcome measure(s)
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Maternal anxiety two weeks post scan as measured by the State Trait Anxiety Inventory (STAI) (Speilberger, 1983)
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Secondary outcome measure(s)
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1. Maternal anxiety (STAI) at baseline and immediately following scan
2. Maternal knowledge about the purpose and effectiveness of the second trimester scan
3. Maternal anxiety measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)
4. Uptake for the 5 separate components of the second trimester scan
5. Maternal anxiety (STAI) following a subnormal result from the second trimester scan at 30 weeks gestation and 6 weeks postnatal
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Sources of funding
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University of Newcastle upon Tyne (UK) - an own account trial
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Trial website
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Publications
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Contact name
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Prof
Steven
Robson
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Address
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Department of Obstetrics and Gynaecology
3rd Floor
William Leech Building
University of Newcastle upon Tyne
Claremont Road
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE1 7RU
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Country
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United Kingdom
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Sponsor
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Newcastle upon Tyne Hospitals NHS Trust (UK)
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Address
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Research and Development
Royal Victoria Infirmary
Queen Victoria Road
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE1 4LP
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Country
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United Kingdom
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Date applied
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07/09/2005
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Last edited
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17/09/2009
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Date ISRCTN assigned
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17/11/2005
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