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A randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation
DOI 10.1186/ISRCTN07823656
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation
Scientific title
Acronym TOPS
Serial number at source HTA 03/11/02
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Pregnancy
Participants - inclusion criteria Women requesting and accepted for termination of pregnancy at less than 14 weeks gestation
Participants - exclusion criteria Not provided at time of registration.
Anticipated start date 01/05/2005
Anticipated end date 31/08/2008
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration.
Interventions Medical termination versus surgical termination
Primary outcome measure(s) Not provided at time of registration.
Secondary outcome measure(s) Not provided at time of registration.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 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
Contact name Prof  Steve  Robson
  Address School of Surgical & Reproductive Sciences
William Leech Building
University of Newcastle
Framlington Place
  City/town Newcastle upon Tyne
  Zip/Postcode NE2 4HH
  Country United Kingdom
  Tel +44 (0)191 222 7157
  Fax +44 (0)191 2228988
  Email s.c.robson@ncl.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 18/05/2005
Last edited 01/08/2012
Date ISRCTN assigned 20/05/2005
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