Managing high-grade cervical lesions in women planning future pregnancies
Conservative Management of Patients Diagnosed With High-grade Squamous Intraepithelial Lesions (H-SIL) Who Have Pregnancy Intentions: a Prospective Observational Study
This study is testing if women of childbearing age with high-grade cervical lesions can safely manage their condition without immediate surgery and if the lesions might go away on their own over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04783805 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the rates of spontaneous regression of high-grade squamous intraepithelial lesions (HSIL) in women of reproductive age who prefer conservative management instead of immediate surgical treatment. Conducted at a tertiary hospital, the study will follow participants with regular colposcopy, cytology, HPV testing, and biopsies over a period of up to 24 months. The goal is to determine whether conservative management can be safely recommended for women of childbearing potential, regardless of age, while monitoring for any progression of lesions.
Who should consider this trial
Good fit: Ideal candidates are women of reproductive age with aspirations for future pregnancies who accept conservative management.
Not a fit: Patients who are currently pregnant, immunosuppressed, or have a diagnosis of cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer alternative to surgery for women with HSIL, preserving their reproductive options.
How similar studies have performed: Previous studies have shown promising results for conservative management of HSIL, particularly in younger women, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Reproductive age and aspirations of future pregnancies * Acceptance of conservative management * Commitment to attend scheduled follow-up visits * Colposcopy with transformation zone (ZT) type 1 or 2 (fully visible squamous-columnar union) with lesion with grade 2 changes visible in its entirety. No endocervical involvement * Colposcopy with grade 2 changes that are not extensive: \<50% of the cervical surface Exclusion Criteria: * Pregnancy at first visit or during follow-up. * Immunosuppression (either iatrogenic or due to human immunodeficiency virus (HIV)) * Suspected or diagnosed Atypical Glandular Cells (ACG), In Situ Adenocarcinoma (AIS) or Cervical Cancer (CC)
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Nerea Nerea — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study coordinator: Natalia Teixeira, MD, Ph.D.
- Email: nteixeira@santpau.cat
- Phone: +34604311873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.