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 |
| Protocol serial number | MPC 135 |
| Sponsor | Camden NHS Primary Care Trust (UK) |
| Funders | The Moulton Charitable Foundation (UK), CliniMed (UK) (provides Instillagel® and placebo) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre, randomised, placebo-controlled, double-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | lignocaine (Instillagel®) |
| Primary outcome measure(s) |
Pain scores at the end of the insertion procedure. Pain scores will be assessed visually using a numerical rating scale of 1-10. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 28/02/2010 |
| Reason abandoned (if study stopped) | Lack of funding/scholarship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| Key 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 |
| Key exclusion criteria | Women choosing an IUD/IUS, for whom this is not an appropriate choice of contraception |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Research Unit
London
W1T 4PL
United Kingdom
W1T 4PL
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
