A randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation

ISRCTN	ISRCTN07823656
DOI	https://doi.org/10.1186/ISRCTN07823656
Secondary identifying numbers	HTA 03/11/02

Submission date: 18/05/2005
Registration date: 20/05/2005
Last edited: 01/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Steve Robson
Scientific

School of Surgical & Reproductive Sciences
William Leech Building
University of Newcastle
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 7157
Email	s.c.robson@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	TOPS
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Pregnancy
Intervention	Medical termination versus surgical termination
Intervention type	Other
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/05/2005
Completion date	31/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration.
Key inclusion criteria	Women requesting and accepted for termination of pregnancy at less than 14 weeks gestation
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/05/2005
Date of final enrolment	31/08/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Surgical & Reproductive Sciences

Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	Narrative review	17/07/2008		Yes	No
Results article	results	01/11/2009		Yes	No