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ISRCTN
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ISRCTN07823656
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ClinicalTrials.gov identifier
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Public title
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A randomised preference trial of medical versus surgical termination of pregnancy less then 14 weeks' gestation
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Scientific title
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Acronym
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TOPS
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Serial number at source
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HTA 03/11/02
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Study hypothesis
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This trial will determine the acceptability, efficacy and cost of medical and surgical termination of pregnancy using a randomised preference design. Acceptability will be determined by the proportion of women who would choose their randomised method again (primary outcome). Information on strength of preference, as determined by willingness to pay, and experiences of the medical and surgical procedures, as determined by a rating scale and adjective checklist, will be collected from all women. A conjoint analysis and semi-structured interviews to be conducted in a separate group of non-pregnant women will help build a conceptual model of preferences that will be explored in a subgroup of randomised women. Morbidity, as assessed by unplanned surgical intervention and unplanned overnight stay or readmission, as well as the prevalence of key symptoms and psychological outcomes (anxiety, depression and the impact of the event) will be determined at 2 weeks and 3 months after the procedure. A full cost-effectiveness analysis will be undertaken.
Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/07/2008 to 31/08/2008.
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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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Pregnancy
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Participants - inclusion criteria
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Women requesting and accepted for termination of pregnancy at less than 14 weeks gestation
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/05/2005
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Anticipated end date
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31/08/2008
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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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Not provided at time of registration.
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Interventions
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Medical termination versus surgical termination
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Primary outcome measure(s)
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Not provided at time of registration.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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1. 2008 Narrative review in http://www.ncbi.nlm.nih.gov/pubmed/18637178
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19906334
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Contact name
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Prof
Steve
Robson
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Address
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School of Surgical & Reproductive Sciences
William Leech Building
University of Newcastle
Framlington Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Tel
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+44 (0)191 222 7157
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Fax
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+44 (0)191 2228988
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Email
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s.c.robson@ncl.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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18/05/2005
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Last edited
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10/12/2009
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Date ISRCTN assigned
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20/05/2005
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