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 |
| Protocol serial number | HTA 03/11/02 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
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 |
|---|---|
| s.c.robson@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
School of Surgical & Reproductive Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No | |
| Other publications | Narrative review | 17/07/2008 | Yes | No |
