Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022

NCT05595252 | Unknown DMC

• 1 other identifier: 2022PI157/EUDRACT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive. Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist. The cervical smear is therefore an important step of the first consultation during pregnancy In the case of pathological results, colposcopies with biopsies are performed, frequently finding CIN 1 to 3. (cervical intraepithelial neoplasia) These CIN lesions evolve slowly and most of the time, treatment can be withheld until the end of the pregnancy. Several studies suggest a higher regression rate in pregnant patients. Our study will evaluate the rate of regression, progression or persistence of these lesions in per and post partum patients in Nancy, between 2014 and 2022. To obtain our results, we will compare the results of per and post partum biopsies in each patient. In a second step, we will study the risk factors of aggravation or on the contrary the protective factors, allowing a faster regression of the lesions

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• progress, persistence or regression of CIN lesion count

  cervical biopsy

  up to one year after delivery

Study Arms (1)

Patients with CIN lésions during pregnancy

Biological: cervical biopsy

Interventions

cervical biopsy BIOLOGICAL

cervical biopsy made during and after pregancy

Patients with CIN lésions during pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

study on patients who were pregnant and have a CIN lesion at the same time, care at the MRUN, the Nancy Régional Maternity between 2014 and 2022

You may qualify if:

• women who have a CIN lesion during pregnancy
• in Nancy, France, MRUN Center
• between 2014 and 2022

You may not qualify if:

• lost of follow up women

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

BENOIT Camille

Nancy, 54000, France

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Camille BENOIT

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant clinical Director

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 26, 2022
• Study Start: January 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

FR (1)