Measurement of the Cervix During Pregnancy According to Age of Conization (MesCon)

March 14, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

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

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Including 84 evaluable patients for the primary endpoint would show a Pearson correlation of at least 0.3 between cervical size and age at conization. These calculations were carried out with a 5% risk of first bilateral species and 80% power. Taking into account the risk of incomplete data, we plan to include 90 patients. A control group of 90 patients will also be recruited.

Description

Inclusion Criteria:

  1. Patient referred since January 2008 with pregnancy between 2008 and 2017
  2. Pregnancy after conisation
  3. Cervix size between 21 and 24 SA before any obstetric event
  4. Control group: parity matching, asymptomatic patients

Exclusion Criteria:

  1. Threat of late miscarriage,
  2. Premature rupture of membranes before cervical echography,
  3. Other pregnancies after study of 1st pregnancy after conisation,
  4. No measurement of the conization specimen,
  5. Lost to follow-up,
  6. Age <18
  7. Twin Pregnancies
  8. Patient under guardianship

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
a group of women who have been conized
Previous conization
Other: Previous conization
a group of women who have been conized,
control group with asymptomatic patients
on routine second trim no previous conization
Other: no previous conization
group with asymptomatic patients on routine second trimester echography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main objective is to study the correlation between the size of the cervix and the age at conization. age at conization
Time Frame: 1 day
Cervix length Measured during the second semester echography
1 day

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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)

February 19, 2018

Primary Completion (Anticipated)

July 19, 2019

Study Completion (Anticipated)

August 19, 2019

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PI2017_843_0021

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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