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Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Summary
Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (\<30 years), but evidence is insufficient on whether it is also advisable for older women. This study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age. This is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization. All patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.
Official title: Conservative Management of Patients Diagnosed With High-grade Squamous Intraepithelial Lesions (H-SIL) Who Have Pregnancy Intentions: a Prospective Observational Study
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2021-03-03
Completion Date
2027-12-31
Last Updated
2021-03-05
Healthy Volunteers
No
Conditions
Interventions
Conservative management with regular follow-up
Women will be followed-up every 4 months, with colposcopy and cytology at each visit.
Conization
Women with progression of HSIL, HSIL persistence after 24 months of follow-up, or that no longer meet the criteria for surveillance will have conization
Locations (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain