Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Graham

ORCID ID

Contact details

University of Bristol
Division of Primary Care
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
+44 (0)117 9287205
a.graham@bris.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S/13/Graham/98

Study information

Scientific title

Acronym

Study hypothesis

Principle research questions:
1. To determine the availability of EC in Avon for the under 16s
2. To develop an intervention in schools, delivered by teachers, to increase teenagers knowledge about EC
3. To evaluate the effectiveness of the intervention in a randomised controlled trial (RCT) in schools in Avon, using a cluster based design

Ethics approval

Not provided at time of registration

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Pregnancy; emergency contraception

Intervention

Added 12/01/10:
Teachers gave a single lesson on emergency contraception to year 10 pupils. The teachers had previously received in-service training on giving the lesson. The pupils were actively involved during the lesson.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To improve awareness of EC amongst 14/15 year olds in Avon

Secondary outcome measures

1. To map the provision of EC for the under 16s in Avon
2. To evaluate the effectiveness of a school based, teacher led, intervention to improve knowledge of the time limits for use of EC
3. To obtain data on pupils knowledge and attitudes towards EC; where they believe EC can be obtained, what they believe the side effects to be, how effective EC is, and how they view the safety of EC
4. To obtain data within this sample, of rates of sexual activity and use of EC

Overall trial start date

01/10/1998

Overall trial end date

01/10/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Year 10 pupils (age 14-15 years) in 24 schools from the four Local Education Authorities that make up Avon Health Authority

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3794 (1974 boys; 1820 girls; 24 schools) (added 12/01/10, see publication)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/1998

Recruitment end date

01/10/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2PR
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12016180

Publication citations

  1. Results

    Graham A, Moore L, Sharp D, Diamond I, Improving teenagers' knowledge of emergency contraception: cluster randomised controlled trial of a teacher led intervention., BMJ, 2002, 324, 7347, 1179.

Additional files

Editorial Notes