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 of protocol

Not provided at time of registration

Contact information

Prof Judith Stephenson
Scientific

Research Unit
Margaret Pyke Centre
73 Charlotte Street
London
W1T 4PL
United Kingdom

Phone	+44 (0)20 7530 3619
Email	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 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
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
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 number of participants	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

England
United Kingdom

Study participating centre

Research Unit

London
W1T 4PL
United Kingdom

Sponsor information

Camden NHS Primary Care Trust (UK)
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
Email	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