Condition category
Pregnancy and Childbirth
Date applied
18/05/2005
Date assigned
20/05/2005
Last edited
01/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Steve Robson

ORCID ID

Contact details

School of Surgical & Reproductive Sciences
William Leech Building
University of Newcastle
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 7157
s.c.robson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/11/02

Study information

Scientific title

Acronym

TOPS

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.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pregnancy

Intervention

Medical termination versus surgical termination

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/05/2005

Overall trial end date

31/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women requesting and accepted for termination of pregnancy at less than 14 weeks gestation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/05/2005

Recruitment end date

31/08/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Surgical & Reproductive Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Narrative review

    Lie ML, Robson SC, May CR, Experiences of abortion: a narrative review of qualitative studies., BMC Health Serv Res, 2008, 8, 150, doi: 10.1186/1472-6963-8-150.

  2. Results

    Robson SC, Kelly T, Howel D, Deverill M, Hewison J, Lie ML, Stamp E, Armstrong N, May CR, Randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation (TOPS)., Health Technol Assess, 2009, 13, 53, 1-124, iii-iv, doi: 10.3310/hta13530.

Additional files

Editorial Notes