Condition category
Pregnancy and Childbirth
Date applied
25/07/2008
Date assigned
21/08/2008
Last edited
20/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.camdenpct.nhs.uk

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

Publication citations

Additional files

Editorial Notes