Status:
UNKNOWN
The IMAP Study Improving Management of Mildly Abnormal Pap Smears
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Family Planning Association New South Wales
Conditions:
Cervix Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
The study compares the psychosocial outcomes of different management strategies for women with minor atypia (including 'HPV effect') detected on Pap smears: conventional management (a repeat Pap smear...
Detailed Description
Women diagnosed with minor atypia following a routine Pap smear will be randomised into one of the three management arms of the study (a) HPV DNA test, (b) Decision Aid (DA) with choice of management,...
Eligibility Criteria
Inclusion
- Women with ONLY the following results on a routine Pap smear:
- Low grade epithelial abnormality;
- Minor changes in squamous cell;
- Minor changes in squamous cells with appearances consistent with Papillomavirus
- Women aged between 18-70 years
Exclusion
- Women who are pregnant or planning to become pregnant in the next 12 months
- Women with previous Pap smear abnormality for 2 years.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00119509
Start Date
January 1 2004
End Date
April 1 2008
Last Update
April 25 2007
Active Locations (7)
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1
North Coast Community Health Centre
Port Macquarie, New South Wales, Australia, 2444
2
Family Planning Association
Sydney, New South Wales, Australia, 2000
3
Taree Community Health Centre
Taree, New South Wales, Australia, 2430
4
Illawarra Women's Health Centre
Warilla, New South Wales, Australia, 2528