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ID04783805

Study of Conservative Management for High-Grade Cervical Lesions in Women Planning Pregnancy

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2021-03-05

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to analyze spontaneous regression rates of high-grade squamous intraepithelial lesions HSIL, including CIN2 and CIN3, in women of reproductive age. The study focuses on whether conservative management without immediate surgery is safe for women who want to have children in the future, regardless of age. It addresses the uncertainty about managing HSIL in women older than 30, as most evidence supports conservative care mainly in younger women under 30. Women diagnosed with HSIL who choose conservative management will be followed regularly with colposcopy and cytology every 4 months. Biopsies are done when needed based on colposcopic changes. HPV testing will be performed every 8 to 12 months. If HSIL persists after 24 months or worsens, or if the patient no longer meets conservative management criteria, cervical conization surgery will be recommended. Participants will be grouped based on lesion regression or whether they undergo conization. Participants will attend follow-up visits every 4 months for at least 2 years, including colposcopy and cytology assessments, with biopsies as clinically indicated. Researchers will monitor lesion changes, HPV status, and cytology results to evaluate spontaneous regression, persistence, or progression of HSIL. Data on demographics, smoking, sexual history, and HPV vaccination will be collected to identify factors linked to lesion regression. The study aims to safely reduce surgical interventions and support effective surveillance strategies in women wishing to preserve fertility.

CONDITIONS

Brief Title

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Research Team

N

Natalia Teixeira, MD, Ph.D.

N

Nerea Nerea, MD

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