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

October 25, 2022 updated by: MARTIN Elena, Central Hospital, Nancy, France

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • BENOIT Camille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • lost of follow up women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CIN lésions during pregnancy
Biological: cervical biopsy
cervical biopsy made during and after pregancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progress, persistence or regression of CIN lesion count
Time Frame: up to one year after delivery
cervical biopsy
up to one year after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Camille BENOIT, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI157/EUDRACT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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