Does topical anaesthetic gel reduce pain/discomfort during intrauterine device (IUD)/intrauterine system (IUS) insertion? A randomised, placebo-controlled, double-blind trial
| ISRCTN | ISRCTN83819888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83819888 |
| Secondary identifying numbers | MPC 135 |
- Submission date
- 25/07/2008
- Registration date
- 21/08/2008
- Last edited
- 20/11/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Judith Stephenson
Scientific
Scientific
Research Unit
Margaret Pyke Centre
73 Charlotte Street
London
W1T 4PL
United Kingdom
| Phone | +44 (0)20 7530 3619 |
|---|---|
| judith.stephenson@ucl.ac.uk |
Study information
| Study design | Single-centre, randomised, placebo-controlled, double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet |
| Scientific title | Does topical anaesthetic gel (Instillagel®) reduce pain discomfort during insertion of intrauterine contraception? A randomised, placebo-controlled, double-blind trial |
| Study hypothesis | Intrauterine device (IUD)/intrauterine system (IUS) are highly effective, long-acting, reversible methods of contraception, and increasing uptake of these methods among women in the UK and elsewhere will reduce unintended pregnancies. Fear or experience of pain during insertion constitute an important barrier to uptake of these methods. Reliable evidence about reducing pain or discomfort during insertion is essential to: 1. Improve the experience for women having an IUD/IUS fitted and advise them appropriately 2. Provide more evidence based guidelines for health care professionals in IUD/IUS insertion |
| Ethics approval(s) | To be submitted as of 25/07/2008 |
| Condition | Unintended pregnancy and abortion |
| Intervention | 2% lignocaine gel (Instillagel®; topical) or an inert equivalent of it will be provided by the manufacturer of Instillagel®. This will be coded and the code only released at the end of the trial. Neither the woman, or the clinician (nor statistician) will be aware of the active/placebo status. Please use the following contact details to request a patient information sheet: Miss Heidi Chandler Study Co-ordinator University College London (UCL) Research Unit Margaret Pyke Centre 73 Charlotte Street London, W1T 4PL United Kingdom Email: hchandler@gum.ucl.ac.uk Please note that this trial was stopped in March 2009. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | lignocaine (Instillagel®) |
| Primary outcome measure | Pain scores at the end of the insertion procedure. Pain scores will be assessed visually using a numerical rating scale of 1-10. |
| Secondary outcome measures | Pain scores relating to the use of the Allis forceps prior to IUD/IUS insertion. Pain scores will be assessed visually using a numerical rating scale of 1-10. |
| Overall study start date | 01/09/2008 |
| Overall study end date | 28/02/2010 |
| Reason abandoned (if study stopped) | Lack of funding/scholarship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Participant inclusion criteria | 1. Women choosing an IUD/IUS, for whom this is an appropriate choice of contraception 2. Between the ages of 16 and 45 |
| Participant exclusion criteria | Women choosing an IUD/IUS, for whom this is not an appropriate choice of contraception |
| Recruitment start date | 01/09/2008 |
| Recruitment end date | 28/02/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Research Unit
London
W1T 4PL
United Kingdom
W1T 4PL
United Kingdom
Sponsor information
Camden NHS Primary Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
Research Unit
3rd Floor West Wing
St Pancras Hospital
St Pancras Way
London
NW1 0PE
England
United Kingdom
| Phone | +44 (0)20 7530 5375 |
|---|---|
| angela.williams@camdenpct.nhs.uk | |
| Website | http://www.camdenpct.nhs.uk |
Funders
Funder type
Charity
The Moulton Charitable Foundation (UK)
No information available
CliniMed (UK) (provides Instillagel® and placebo)
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 |
