Contact information
Type
Scientific
Primary contact
Prof Judith Stephenson
ORCID ID
Contact details
Research Unit
Margaret Pyke Centre
73 Charlotte Street
London
W1T 4PL
United Kingdom
+44 (0)20 7530 3619
judith.stephenson@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MPC 135
Study information
Scientific title
Does topical anaesthetic gel (Instillagel®) reduce pain discomfort during insertion of intrauterine contraception? A randomised, placebo-controlled, double-blind trial
Acronym
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
To be submitted as of 25/07/2008
Study design
Single-centre, randomised, placebo-controlled, double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet
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
Phase
Not Specified
Drug names
lignocaine (Instillagel®)
Primary outcome measures
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 trial start date
01/09/2008
Overall trial end date
28/02/2010
Reason abandoned
Lack of funding/scholarship
Eligibility
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 type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
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
United Kingdom
Trial participating centre
Research Unit
London
W1T 4PL
United Kingdom
Sponsor information
Organisation
Camden NHS Primary Care Trust (UK)
Sponsor details
Research & Development Department
Research Unit
3rd Floor West Wing
St Pancras Hospital
St Pancras Way
London
NW1 0PE
United Kingdom
+44 (0)20 7530 5375
angela.williams@camdenpct.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Moulton Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CliniMed (UK) (provides Instillagel® and placebo)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary